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If you look at last few years
and what I like to call it,
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is this a paradigm step right in
terms of new techniclozy and even like a
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business model perspective. It's opending the
intact content man's been landscape. Welcome to
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life sciences accelerated, a podcast where
we discuss experiences and groundbreaking innovations in compliance
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and technology, from molecule to market. Tune in for in depth interviews with
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wellknown thought leaders and renowned subject matter
experts with unparalleled knowledge in the technology and
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life sciences industry. Innovative, helpful
and thought provoking. This is life sciences
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accelerated. Today we're talking about content
and document managements in life sciences and I
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have two guests with me today.
Of chall Sharma, he's the VP of
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digital transformation at USD on life sciences. Butch all develops core competencies using emerging
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technologies to help customers fast track their
digital transformation achieve high impact business outcomes.
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Is More than twenty years of experience
life sciences. I also have Manuvora.
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He is the managing director of life
sciences at box. Many is also an
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industry veteran with two decades of experience
to point content management solutions for life sciences
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while running operations within several its functions, supporting drug discovery all the way to
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commercialization. And thank you both for
being here today. Thank you all right.
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Well, let's get right into this. So money. I'll start with
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you tell us about GXPD and what
it means and why content management is also
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so different specifically for regulated businesses like
life sciences. Sure, GXP is a
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set of standards that are applied to
different functions that are in the clinical parts
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of life sciences value chain. So
it could be applied to clinical areas where
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there's the controls are called GCP,
in the laboratory areas it called G LP,
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and you get the you get the
motion there and then there's on the
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man attracting side, is GMP.
So that x is actually just a variable.
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So it's a set of it's a
set of standards that are applied to
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all these errors that require regulatory controls
across the life sciences valued me and in
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terms of regulatory challenges for managing contents. You know, things have been changing
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over the last a couple of decades. In the before and after you know
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it. We the way we work
has completely changed. And alongside that there's
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different there's different types of challenges that
Cud of that come across for regulatory content.
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So first one is overhead, so
overhead in terms of time, cost
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and resources. That compliances traditionally been
seen as a burden that slows down progress,
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and it's the checks and house is
part of life sciences and many times
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it's subjective. The second ones also
globalization, like activations with clinical sites or
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regulatory rules. They're all happening beyond
country boundaries now than they were and twenty
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years ago, and this this creates
layer of complexity for a collaboration, but
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also creates a lot of contents brawl. Last one, on least, is
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also a digital waltz. These digital
walls were erected in the past to keep
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content secure, but you know that
that doesn't work anymore in a scenario where
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you're working with folks and partners and
vendors outside your digital wall. So the
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philosophy of content security has changed from
protective perimeter to protect the flow of data.
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Gotcha, okay, and vishaw.
So my next questions for you.
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You've been in the consulting space for
a long time. How is content management
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evolved over that just the last few
years, especially with life science companies as
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they make their you know, go
on this digital transformation journey and many of
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them really moving their technologies to the
cloud. Sure that's a great question,
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Ryan. So this Manusa said,
like, if you look at last few
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years and what I like to call
is this the paradigm step right in terms
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of new technology and even like a
business model perspective, it's opending the entire
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content management landscape. So, just
to give an example, if you look
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at from the time period perspective,
what I like to call the pet the
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thousand and ten, just think about
like those days were dominated by legacy application
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hosted on prem or in private data
standards. Right, they were kind of
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more likely best of bread, but
points solution. A lot of vendors were
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like approaching from a tool kid tide
of faid, trying to build something for
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you. And all these were built
on legacy technology stack with a very limited
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configurability. Right and all, if
you want it, scalability, if you
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wanted performance, they came in a
very, very high cause and obviously,
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as Manu state, the compliance was
always the burden for especially for life sciences
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industry. And High Implementation and the
validation cost in general. And if you
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kind of hast forward by let's say
five years, between two thousand and ten
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and fifteen, that's where you saw
the emergence of all these new cloud based
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technology and the vendors. And then
all of a sudden traditional vendors were trying
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to catch up, right, trying, and they were forced by market condition,
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not their internal innovation, right,
and then they started building this book
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what we call the hybrid type of
solution, and the technology stack was hybrid,
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part on praying part, like little
bit on cloud services, but not
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fully on the cloud side of it. And it still the scalability and the
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performance came out a very, very
high cause. Now, Hostpo word and
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look at last few years. So
what happened? And that's where the paradigms
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stay have right now. All of
a sudden you started seeing digital, native,
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the bone in the cloud type of
solutions and the vendors built on modern
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platform, the technology stack with very
high configurability at low cost, and technology
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is as manuster. Security is kind
of key right to all these technologies and
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the solutions were designed ground up with
the cloud services in mind. So what
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I mean by that is the all
the elasticity you need, all the security
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you need, all the privacy that
you have to have in mind. All
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would will ground up, not after
thought, and all of a sudden what
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happened was paradigms sifted. Now you
get the scalability and the performance at very
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low cart yeah. Now, if
you really think about from the life sciences
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perspective, right, why they were
very slow in terms of adopting some of
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these so as manuster compliance was always
the burden and security and the data protection.
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We hear about it, and leak
is how to prevent it, and
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all the international regulation around Gdpr,
and then, in general, the governance
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and the data integrity, where you
needed some expertise in house and they lack
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that. They last some technically skill
adopting new technology as well. And the
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biggest barrier in my opinion, was
it's not the first time validation, but
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this continues to state up readiness for
regulatory inspection. That was actually preventing life
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sences company for adopting all these new
emerging techniques and money. So so boxing
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USDM. They've had a partnership now
for for many years and built a solution
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to manage cloud compliance. Can you
tell us about how this partnership came about
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and how you actually manage this cloud
compliance? Sure I can get into that.
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So box is only a leader in
the content collaboration space and we were
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process of extending our offering in two
content services, with platform offerings etc.
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But in order to fully server life
sciences market, we needed to be able
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to have a regulated or a gxb
off and to that end we know we
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definitely need it outside expertise. So
we started working with US DM as early
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as two thousand and fifteen to see
if this was even a possibility. We
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have a one platform philosophy here box, and that had to extend to our
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GXP offering as well, which is
counter intuitive to what the industry normally applies
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so towards these models. So we
had to come up with a new model
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together. So, together with USDM, we designed a service that's now at
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the forefront of gxped models, with
agile validation and automated, continuous automated testing.
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It provides essentially unparalleled visibility to compliance
team and finally, our end users
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are able to actually reap the benefits
of box while the overhead of compliance was
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taken on by box and USDM Gotcha, and this single platform thing that you
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mentioned to me that sticks out and
Vichall US DM and box that recently introduced
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a product called unify cloud compliance and
that now includes document management services provided by
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compliance its quest. Can you tell
us about how this product came about and
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how it further addresses life science business
needs? Yeah, absolutely. As a
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matter of fact, we are very
excited about department step with box and compliance
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quest in this case where we kind
of collaborated. If we go back when
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we wor kind of contemplating this unify
compliance cloud as a solution, we wanted
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to make sure we harness the power
of the box. That's when you said
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is very good at the content,
write the content, collaboration and making it
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easy and secure from a collaboration perspective
on internally within the organization, but externally
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as what so obviously we wanted to
harness that power, but we wanted to
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extend beyond that and and wanted to
bring some of the other youth cases what
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we felt much needed in the marketplace
for the life science is organization. To
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give you an example, as I
said, we wanted to build on bark,
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but we wanted to add what we
call the process centric workflows, so
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these are predefined document life cycle management
or training management and and the very structured
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change management process as part of it. So think of this one like on
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a single platform concept. We wanted
to extend and provide more workflows to manage
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additional business processes for life sense is
organization. The other thing we wanted to
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make sure work. Continuing on the
theme of like on a competitive landscape,
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we wanted to bring something as a
value. It's always on, always secure
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because it's built on modern platform.
At the same time, we could offer
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something like this in a very competitive
pricing. That's what and I believe by
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partnering with both box and compliance quest
in this case, we address those concerned
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and I brought that value to a
much larger life senses organization marketplace. Right.
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So we are really, really excited
about buttonstead and so money. We
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talked earlier about this, you know, single interface that was very important to
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you into box and end this newer
solution that box, compliants, quest and
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USTM have developed really does encompass that
that single interface, but at the same
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time there's endless possibilities. That's May
understanding. You talk more about that.
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Yeah, absolutely, so. Yeah, I didn't mention that box grow.
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We have one platform philosophy or of
being in the in the cloud business today
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is this concept of having, you
know, Apis. If you look back
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twenty years ago, ten years ago, even if you needed to, you
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know, move content from one application
to another, you would need to build
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an inigration. I remember when I
used to take a team of engineers four
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weeks to just know something like that
in in a couple of sprints. Nowadays,
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in the cloud world, these applications
are just available as services in the
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cloud. So at box we offer
content services, we have our partners,
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a compliance quest offers application services for
life sciences and the boats are native in
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the clouds. So use the immigrations
are customers are can essentially operate in a
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best room breed stack where they bring
their own capabilities. They want to add
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a new capability in the future,
you can just essentially plug one in and
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at box we have very, very
robust set of API. So essentially,
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even if we don't have a ready
integration then you know, it's very easy
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to build one. It's over shall
what advice do you have for life science
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companies that are redamping their it strategies
and considering this urgent need now to move
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to the cloud. Yeah, absolutely, Ryan, if you allow me to
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go back and just that, and
just the one quick point on the open
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platform side off that. Yeah,
yeah, the technology stack is wonderful and
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Manu highlighted those. And there is
other aspect on the unified compliance cloud as
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well. So if you look at
the business grows right over time and they
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need grows along with it. So
the unify compliance cloud platform also allowed you
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to add additional business use pieces,
like if you want to go deeper into
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the quality side of it, like
if you want to manage your nonconformances,
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your deviation, your coppers, all
those processes can be automated within the theme
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complyanceprame work or the same platform.
So that's the added value we see as
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part of that solution. That's what
now going back to your question, what
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advice do I have for right into
Soviety strategy post and foremost, like,
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I mean all these organizations, whether
you are in merging or mid tide or
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large organization, you have to think
this whole cloud journey as a more of
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a structure journey map, because not
all of your regulated workloads is going to
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move at once. So you have
to think in terms of the cloud,
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as of the framework that has that
flexibility that allows you to get into cloud
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based on your business priority, not
just moving at once. So that's very
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important. The second aspect of that
is the oldest. I mean the whole
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the way we work is changing and
that's changing the customer need, how they're
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gonna address their customer. There in
customer need. So you have to think
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in terms of not only a single
cloud but the multi cloud type of a
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process well as part of your strategy. The second thing I would say is
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consider a compliance like that should be
part of your journey, not after thoughts,
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because moving into cloud, the one
of the benefit is the adoption,
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which happens very, very quickly.
You get all these services administia rather than
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in months, in weeks. So
the compliants has to be built in as
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part of anything that even you're going
to move into the cloud. The other
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thing I like to add into that
is the overall investment philosophy. Right,
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a lot of times what happens is
all these organization they make an investment,
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they buy an application on clouds.
I would like to think that as a
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more of investment on cloud technology,
not just the applications, to fund your
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future innovation. The idea here is
because the cloud actually enables you, and
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I like the school where I heard
this from prom some place, this relentless
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unbundling of value, creating activities from
valor consuming activities, and that's exactly what
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cloud does, or it isn't?
That allowed you to focus on your core
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business, to strint, not having
to worry about the infrastructure of the platform,
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the availability, the security, the
scalability, all that. So those
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are someone advised. I would like
to keep the life sense in woment so
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va Shaw. We've heard recently from
the FTA about computer software assurance, you
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know, this sort of different approach
or revised approach to computer system validation.
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What is what's your sense of the
FDA stand some things like this, especially
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when we talk about, you know, moving our technologies and moving our processes
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to two more of these cloud technologies? Is the FDA behind all of this,
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much like they are with this new
revised CSA approach? Yeah, absolutely,
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Ryan. So, if you really
think about it, the guidelines they
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are talking about, and some of
these actually is partly released already in terms
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of the concept back to regulation is
going to be released sometime in September two
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thousand and twenty, and it's a
major stip if you really think about it.
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So far ID was so focused on
the very traditional the GAMP, or
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more of a computer your system validation. We call it CSP. So it's
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a major stafe towards what they call
the computer software or Staurans, which is
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based on a purely arrest. That's
the core principle around it and they are
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actually acvocating to use and use more
of like automation and bring some of the
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learning that happened in other industry right
and bring that into the life sciences as
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will. So what that actually means
is a lot of times in the past
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we used to take vender supplied piece
of software and then we added our own
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set of testing before any organization can
start using in a production. So that
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paradigm is changing. Now what they
are allowing us to do is go back
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to vendor and rely on their Asturans
in house and leverage that rather than duplicating
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the effort right so that you're not
adding additional testing or documentaries in burdens,
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so to speak, in the process, without getting the real Bennett. So
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they are guiding us to move towards
more of a risk best where there is
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a product, you have a past
in risk of a product. Risk focused
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on those focused on more of a
critical thinking rather than just tolely rely on
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a set of documentation. So in
my opinion it's as a huge theft in
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terms of FD is thinking in general, the regulatory bodies thinking in terms of
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becoming more of a risk bast and
a truly a critical thinking and focus on
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highest risk. A has to improve
overall product, the safety and the quality,
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rather than heavily focused on documentation.
So yes, in my opinion,
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if they's a major staff in terms
of fifty as well, and with a
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little bit of time we have left
here, money what? What advice do
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you have for life science companies that
are exploring content management solutions? Can I
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just getting into this looking at,
you know, cloud technology alternatives. Sure
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you know content is critically important in
a life sciences company, right. That's
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that's where biotax IP resides. And
for if you I manage the smaller biotax
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they're not even commercials, they're not
selling anything. Yet that's the most important
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thing that that they have, that
they need to protect and it orders the
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best security and compliance controls. Most
life sciences already have a content management solution
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in place. You know they'd be
a very loves of the technology adoption curve,
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but they have something in place.
You know, big farm is generally
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riddle with legacy on Premisey cm tools, while the start of biotax are generally
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cloud first and SASS oorented. But
so the strategies are different than the mean
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thing I'll I always recommend, is
to essentially adopt a content strategy and create
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a content of roadmap. So essentially
decide where you want to be as an
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organization on the technology adoption curve,
pick a club strategy and a security framework
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that's going to fit your organization.
That will feed into essentially generating a content
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roadmap and allow you to make decisions
on your content, on your content applications
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for the next two to five years. Is You're not doing more reactive in
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your planning, then you may find
yourselves, you know, invested in one
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point solution that works really well for
the next year, but then your you
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end up buying do three more redundant
systems over the next two years. That
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is since the don't scale up.
That makes sense all right. Well,
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thank you both for joining us today
and for those of you that want more
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information on GXP content and document management, check out our website. That's US
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DMCOM. Or we have tons of
blogs, white papers and webinars on this
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very topic, as well as many
other life sites related topics, and you
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can send us any feedback you have
on our content that you find on our
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website and, of course, the
podcasts that you're listening to here. You
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can email us at US DM at
US DM COM. Thanks again for joining
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us and have a great day.
You've been listening to life sciences accelerated.
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00:19:15.710 --> 00:19:18.750
If you enjoyed this episode, please
subscribe and leave us a review. If
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00:19:18.789 --> 00:19:23.740
you'd like to learn more about strategies
to digitally transform your company and ways to
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streamline your organizations compliance processed, visit
us dmcom. That's US DMCOM. Thanks
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00:19:33.220 --> 00:19:34.259
so much for listening. Until next
time,
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If you look at last few years
and what I like to call it,
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is this a paradigm step right in
terms of new techniclozy and even like a
3
00:00:06.799 --> 00:00:17.870
business model perspective. It's opending the
intact content man's been landscape. Welcome to
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00:00:18.070 --> 00:00:24.539
life sciences accelerated, a podcast where
we discuss experiences and groundbreaking innovations in compliance
5
00:00:24.820 --> 00:00:29.500
and technology, from molecule to market. Tune in for in depth interviews with
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00:00:29.739 --> 00:00:36.250
wellknown thought leaders and renowned subject matter
experts with unparalleled knowledge in the technology and
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00:00:36.450 --> 00:00:42.530
life sciences industry. Innovative, helpful
and thought provoking. This is life sciences
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00:00:42.689 --> 00:00:48.810
accelerated. Today we're talking about content
and document managements in life sciences and I
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00:00:48.890 --> 00:00:51.880
have two guests with me today.
Of chall Sharma, he's the VP of
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digital transformation at USD on life sciences. Butch all develops core competencies using emerging
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technologies to help customers fast track their
digital transformation achieve high impact business outcomes.
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Is More than twenty years of experience
life sciences. I also have Manuvora.
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He is the managing director of life
sciences at box. Many is also an
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industry veteran with two decades of experience
to point content management solutions for life sciences
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while running operations within several its functions, supporting drug discovery all the way to
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commercialization. And thank you both for
being here today. Thank you all right.
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Well, let's get right into this. So money. I'll start with
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you tell us about GXPD and what
it means and why content management is also
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so different specifically for regulated businesses like
life sciences. Sure, GXP is a
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set of standards that are applied to
different functions that are in the clinical parts
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of life sciences value chain. So
it could be applied to clinical areas where
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there's the controls are called GCP,
in the laboratory areas it called G LP,
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and you get the you get the
motion there and then there's on the
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man attracting side, is GMP.
So that x is actually just a variable.
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So it's a set of it's a
set of standards that are applied to
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all these errors that require regulatory controls
across the life sciences valued me and in
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terms of regulatory challenges for managing contents. You know, things have been changing
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over the last a couple of decades. In the before and after you know
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it. We the way we work
has completely changed. And alongside that there's
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different there's different types of challenges that
Cud of that come across for regulatory content.
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So first one is overhead, so
overhead in terms of time, cost
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and resources. That compliances traditionally been
seen as a burden that slows down progress,
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and it's the checks and house is
part of life sciences and many times
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it's subjective. The second ones also
globalization, like activations with clinical sites or
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regulatory rules. They're all happening beyond
country boundaries now than they were and twenty
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years ago, and this this creates
layer of complexity for a collaboration, but
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also creates a lot of contents brawl. Last one, on least, is
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also a digital waltz. These digital
walls were erected in the past to keep
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content secure, but you know that
that doesn't work anymore in a scenario where
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you're working with folks and partners and
vendors outside your digital wall. So the
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philosophy of content security has changed from
protective perimeter to protect the flow of data.
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Gotcha, okay, and vishaw.
So my next questions for you.
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You've been in the consulting space for
a long time. How is content management
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evolved over that just the last few
years, especially with life science companies as
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they make their you know, go
on this digital transformation journey and many of
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them really moving their technologies to the
cloud. Sure that's a great question,
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Ryan. So this Manusa said,
like, if you look at last few
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years and what I like to call
is this the paradigm step right in terms
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of new technology and even like a
business model perspective, it's opending the entire
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content management landscape. So, just
to give an example, if you look
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at from the time period perspective,
what I like to call the pet the
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thousand and ten, just think about
like those days were dominated by legacy application
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hosted on prem or in private data
standards. Right, they were kind of
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more likely best of bread, but
points solution. A lot of vendors were
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like approaching from a tool kid tide
of faid, trying to build something for
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you. And all these were built
on legacy technology stack with a very limited
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configurability. Right and all, if
you want it, scalability, if you
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wanted performance, they came in a
very, very high cause and obviously,
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as Manu state, the compliance was
always the burden for especially for life sciences
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industry. And High Implementation and the
validation cost in general. And if you
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kind of hast forward by let's say
five years, between two thousand and ten
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and fifteen, that's where you saw
the emergence of all these new cloud based
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technology and the vendors. And then
all of a sudden traditional vendors were trying
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to catch up, right, trying, and they were forced by market condition,
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not their internal innovation, right,
and then they started building this book
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what we call the hybrid type of
solution, and the technology stack was hybrid,
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part on praying part, like little
bit on cloud services, but not
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fully on the cloud side of it. And it still the scalability and the
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performance came out a very, very
high cause. Now, Hostpo word and
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look at last few years. So
what happened? And that's where the paradigms
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stay have right now. All of
a sudden you started seeing digital, native,
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the bone in the cloud type of
solutions and the vendors built on modern
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platform, the technology stack with very
high configurability at low cost, and technology
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is as manuster. Security is kind
of key right to all these technologies and
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the solutions were designed ground up with
the cloud services in mind. So what
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I mean by that is the all
the elasticity you need, all the security
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you need, all the privacy that
you have to have in mind. All
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would will ground up, not after
thought, and all of a sudden what
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happened was paradigms sifted. Now you
get the scalability and the performance at very
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low cart yeah. Now, if
you really think about from the life sciences
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perspective, right, why they were
very slow in terms of adopting some of
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these so as manuster compliance was always
the burden and security and the data protection.
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We hear about it, and leak
is how to prevent it, and
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all the international regulation around Gdpr,
and then, in general, the governance
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and the data integrity, where you
needed some expertise in house and they lack
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that. They last some technically skill
adopting new technology as well. And the
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biggest barrier in my opinion, was
it's not the first time validation, but
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this continues to state up readiness for
regulatory inspection. That was actually preventing life
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sences company for adopting all these new
emerging techniques and money. So so boxing
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USDM. They've had a partnership now
for for many years and built a solution
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to manage cloud compliance. Can you
tell us about how this partnership came about
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and how you actually manage this cloud
compliance? Sure I can get into that.
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So box is only a leader in
the content collaboration space and we were
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process of extending our offering in two
content services, with platform offerings etc.
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But in order to fully server life
sciences market, we needed to be able
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to have a regulated or a gxb
off and to that end we know we
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definitely need it outside expertise. So
we started working with US DM as early
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as two thousand and fifteen to see
if this was even a possibility. We
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have a one platform philosophy here box, and that had to extend to our
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GXP offering as well, which is
counter intuitive to what the industry normally applies
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so towards these models. So we
had to come up with a new model
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together. So, together with USDM, we designed a service that's now at
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the forefront of gxped models, with
agile validation and automated, continuous automated testing.
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It provides essentially unparalleled visibility to compliance
team and finally, our end users
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are able to actually reap the benefits
of box while the overhead of compliance was
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taken on by box and USDM Gotcha, and this single platform thing that you
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mentioned to me that sticks out and
Vichall US DM and box that recently introduced
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a product called unify cloud compliance and
that now includes document management services provided by
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compliance its quest. Can you tell
us about how this product came about and
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how it further addresses life science business
needs? Yeah, absolutely. As a
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matter of fact, we are very
excited about department step with box and compliance
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quest in this case where we kind
of collaborated. If we go back when
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we wor kind of contemplating this unify
compliance cloud as a solution, we wanted
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to make sure we harness the power
of the box. That's when you said
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is very good at the content,
write the content, collaboration and making it
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easy and secure from a collaboration perspective
on internally within the organization, but externally
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as what so obviously we wanted to
harness that power, but we wanted to
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extend beyond that and and wanted to
bring some of the other youth cases what
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we felt much needed in the marketplace
for the life science is organization. To
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give you an example, as I
said, we wanted to build on bark,
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but we wanted to add what we
call the process centric workflows, so
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these are predefined document life cycle management
or training management and and the very structured
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change management process as part of it. So think of this one like on
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a single platform concept. We wanted
to extend and provide more workflows to manage
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additional business processes for life sense is
organization. The other thing we wanted to
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make sure work. Continuing on the
theme of like on a competitive landscape,
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we wanted to bring something as a
value. It's always on, always secure
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because it's built on modern platform.
At the same time, we could offer
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something like this in a very competitive
pricing. That's what and I believe by
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partnering with both box and compliance quest
in this case, we address those concerned
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and I brought that value to a
much larger life senses organization marketplace. Right.
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So we are really, really excited
about buttonstead and so money. We
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talked earlier about this, you know, single interface that was very important to
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you into box and end this newer
solution that box, compliants, quest and
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USTM have developed really does encompass that
that single interface, but at the same
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time there's endless possibilities. That's May
understanding. You talk more about that.
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Yeah, absolutely, so. Yeah, I didn't mention that box grow.
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We have one platform philosophy or of
being in the in the cloud business today
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is this concept of having, you
know, Apis. If you look back
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twenty years ago, ten years ago, even if you needed to, you
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know, move content from one application
to another, you would need to build
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an inigration. I remember when I
used to take a team of engineers four
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weeks to just know something like that
in in a couple of sprints. Nowadays,
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in the cloud world, these applications
are just available as services in the
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cloud. So at box we offer
content services, we have our partners,
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a compliance quest offers application services for
life sciences and the boats are native in
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the clouds. So use the immigrations
are customers are can essentially operate in a
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best room breed stack where they bring
their own capabilities. They want to add
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a new capability in the future,
you can just essentially plug one in and
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at box we have very, very
robust set of API. So essentially,
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even if we don't have a ready
integration then you know, it's very easy
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to build one. It's over shall
what advice do you have for life science
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companies that are redamping their it strategies
and considering this urgent need now to move
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to the cloud. Yeah, absolutely, Ryan, if you allow me to
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go back and just that, and
just the one quick point on the open
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platform side off that. Yeah,
yeah, the technology stack is wonderful and
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Manu highlighted those. And there is
other aspect on the unified compliance cloud as
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well. So if you look at
the business grows right over time and they
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need grows along with it. So
the unify compliance cloud platform also allowed you
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to add additional business use pieces,
like if you want to go deeper into
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the quality side of it, like
if you want to manage your nonconformances,
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your deviation, your coppers, all
those processes can be automated within the theme
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complyanceprame work or the same platform.
So that's the added value we see as
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part of that solution. That's what
now going back to your question, what
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advice do I have for right into
Soviety strategy post and foremost, like,
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I mean all these organizations, whether
you are in merging or mid tide or
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large organization, you have to think
this whole cloud journey as a more of
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a structure journey map, because not
all of your regulated workloads is going to
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move at once. So you have
to think in terms of the cloud,
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as of the framework that has that
flexibility that allows you to get into cloud
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based on your business priority, not
just moving at once. So that's very
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important. The second aspect of that
is the oldest. I mean the whole
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the way we work is changing and
that's changing the customer need, how they're
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gonna address their customer. There in
customer need. So you have to think
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in terms of not only a single
cloud but the multi cloud type of a
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process well as part of your strategy. The second thing I would say is
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consider a compliance like that should be
part of your journey, not after thoughts,
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because moving into cloud, the one
of the benefit is the adoption,
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which happens very, very quickly.
You get all these services administia rather than
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in months, in weeks. So
the compliants has to be built in as
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part of anything that even you're going
to move into the cloud. The other
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thing I like to add into that
is the overall investment philosophy. Right,
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a lot of times what happens is
all these organization they make an investment,
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they buy an application on clouds.
I would like to think that as a
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more of investment on cloud technology,
not just the applications, to fund your
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future innovation. The idea here is
because the cloud actually enables you, and
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I like the school where I heard
this from prom some place, this relentless
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unbundling of value, creating activities from
valor consuming activities, and that's exactly what
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cloud does, or it isn't?
That allowed you to focus on your core
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business, to strint, not having
to worry about the infrastructure of the platform,
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the availability, the security, the
scalability, all that. So those
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are someone advised. I would like
to keep the life sense in woment so
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va Shaw. We've heard recently from
the FTA about computer software assurance, you
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know, this sort of different approach
or revised approach to computer system validation.
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What is what's your sense of the
FDA stand some things like this, especially
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when we talk about, you know, moving our technologies and moving our processes
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to two more of these cloud technologies? Is the FDA behind all of this,
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much like they are with this new
revised CSA approach? Yeah, absolutely,
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Ryan. So, if you really
think about it, the guidelines they
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are talking about, and some of
these actually is partly released already in terms
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of the concept back to regulation is
going to be released sometime in September two
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thousand and twenty, and it's a
major stip if you really think about it.
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So far ID was so focused on
the very traditional the GAMP, or
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more of a computer your system validation. We call it CSP. So it's
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a major stafe towards what they call
the computer software or Staurans, which is
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based on a purely arrest. That's
the core principle around it and they are
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actually acvocating to use and use more
of like automation and bring some of the
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learning that happened in other industry right
and bring that into the life sciences as
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will. So what that actually means
is a lot of times in the past
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we used to take vender supplied piece
of software and then we added our own
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set of testing before any organization can
start using in a production. So that
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paradigm is changing. Now what they
are allowing us to do is go back
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to vendor and rely on their Asturans
in house and leverage that rather than duplicating
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the effort right so that you're not
adding additional testing or documentaries in burdens,
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so to speak, in the process, without getting the real Bennett. So
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they are guiding us to move towards
more of a risk best where there is
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a product, you have a past
in risk of a product. Risk focused
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on those focused on more of a
critical thinking rather than just tolely rely on
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a set of documentation. So in
my opinion it's as a huge theft in
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terms of FD is thinking in general, the regulatory bodies thinking in terms of
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becoming more of a risk bast and
a truly a critical thinking and focus on
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highest risk. A has to improve
overall product, the safety and the quality,
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rather than heavily focused on documentation.
So yes, in my opinion,
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if they's a major staff in terms
of fifty as well, and with a
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little bit of time we have left
here, money what? What advice do
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you have for life science companies that
are exploring content management solutions? Can I
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just getting into this looking at,
you know, cloud technology alternatives. Sure
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you know content is critically important in
a life sciences company, right. That's
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that's where biotax IP resides. And
for if you I manage the smaller biotax
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they're not even commercials, they're not
selling anything. Yet that's the most important
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thing that that they have, that
they need to protect and it orders the
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best security and compliance controls. Most
life sciences already have a content management solution
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in place. You know they'd be
a very loves of the technology adoption curve,
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but they have something in place.
You know, big farm is generally
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riddle with legacy on Premisey cm tools, while the start of biotax are generally
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cloud first and SASS oorented. But
so the strategies are different than the mean
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thing I'll I always recommend, is
to essentially adopt a content strategy and create
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a content of roadmap. So essentially
decide where you want to be as an
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organization on the technology adoption curve,
pick a club strategy and a security framework
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that's going to fit your organization.
That will feed into essentially generating a content
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roadmap and allow you to make decisions
on your content, on your content applications
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for the next two to five years. Is You're not doing more reactive in
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your planning, then you may find
yourselves, you know, invested in one
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point solution that works really well for
the next year, but then your you
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end up buying do three more redundant
systems over the next two years. That
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is since the don't scale up.
That makes sense all right. Well,
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thank you both for joining us today
and for those of you that want more
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information on GXP content and document management, check out our website. That's US
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00:18:45.009 --> 00:18:51.089
DMCOM. Or we have tons of
blogs, white papers and webinars on this
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00:18:51.250 --> 00:18:55.170
very topic, as well as many
other life sites related topics, and you
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00:18:55.250 --> 00:18:57.759
can send us any feedback you have
on our content that you find on our
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website and, of course, the
podcasts that you're listening to here. You
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00:19:03.000 --> 00:19:07.519
can email us at US DM at
US DM COM. Thanks again for joining
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00:19:07.559 --> 00:19:15.509
us and have a great day.
You've been listening to life sciences accelerated.
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00:19:15.710 --> 00:19:18.750
If you enjoyed this episode, please
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you'd like to learn more about strategies
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00:19:23.859 --> 00:19:33.180
streamline your organizations compliance processed, visit
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00:19:33.220 --> 00:19:34.259
so much for listening. Until next
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