Pharmaceutical Commerce - May/June 2017 - 22

Information Technology
been released to date.
The truth of the matter is that it is not
the regulator's role to instruct companies
on how to meet regulations. In some ways
that is a good thing, because it allows for
innovation and results in better ways to
meet the same goals (or exceed them).
Another guidance document from FDA, the
General Principles of Software Validation,
For purposes of this guidance,
FDA considers sof t ware validation to
be conf ir mation by e x amination and
provision of objective evidence that software
specifications conform to user needs and
intended uses, and that the particular
requirements implemented through software
can be consistently fulfilled.
In absence of direct guidance from FDA
(or other regulatory bodies) on the use of
cloud computing platforms, companies and
vendors should concentrate on meeting
the stated requirements, not trying to
retrofit the same process that was used for
on-premise software if it does not make
To sum up the challenge, how do we
properly validate systems (provide that
objective evidence) that are deployed to the
cloud across multiple tenants in an efficient
way, whereas the process allows for more
frequent updates to the software across the
entire multi-tenant user base?
The practice of automated validation
For traditional on-premise software
solutions, validation could take 4-8 or more
months for a single system. While spending
over half a year executing a validation
process is expensive and time consuming
for traditional on-premise deployments, it
might be outright impossible in a cloudbased scenario where vendors are typically
deploying new software versions several
times per year. With automated validation,
execution is reduced from months to days.
True automated testing is built into the
software development process. This means
that as developers are writing code, they
are also writing scripts to test each piece

of code. A good overall test automation
program will include thousands of unit
tests, integration tests and other tests all
the way up the stack to functional tests. The
functional tests become the backbone of
the validation process. By simultaneously
writing the validation scripts along with
the code and deploying those tests into a
framework that executes at regular intervals,
the application is being tested at every stage
of development. Running a full validation
process at the end of the release is great,
but failures at this stage are identifying
defects that may have been introduced into
the product weeks or months earlier. By
running your automated test suite at regular
intervals, defects surface immediately and
can be addressed closer to the point of
origin. After deployment, there is no reason
to stop running your validation process
at regular intervals, which leads to an
application that is essentially continuously
T h e re a re m a ny m i s co n ce p t i o n s
regarding the requirements of
computer system validation. A common
misconception is that FDA requires
tests to be run by a human being and
signed off with pen to paper. There is no
regulation that dictates that this is the
only way to meet the regulation. What is
required is objective evidence that software
requirements describe the intended use and
that the system meets those needs of the
user. Once you determine alternate ways
to provide objective evidence that can
leverage good automation practices, you
open the possibility that your system can
safely change more often and be quickly
revalidated. If vendors are able to provide
objective evidence of IQ, OQ and even PQ
(Performance Qualification) scenarios,
customers can benefit from similar speedto-value that other industries that have
embraced cloud applications enjoy. The
days of checking off test steps manually on
paper are simply over. With cloud-based
systems, vendors can provide much of the
evidence required for customers to pass
audits. This is difficult for many customers
to grasp, because they are so used to
performing their own manual validation

for on-premise systems. Before selecting
a cloud vendor, customers should fully
understand what level of validation is
provided. In many cases, cloud vendors
provide out-of-the-box validation as soon
as the customer signs. This surprises and
delights pharmaceutical executives who are
new to the world of the cloud.
EQMS and cloud-based systems
The pharmaceutical industry faces
co m p l ex ch a l l e n g e s re s u l t i n g f ro m
r e g u l a t o r y s c r u t i n y, m e r g e r s a n d
acquisitions, parent expirations, and
countless cost-cutting requirements.
Manufacturers, contract research
organizations and virtual companies all
require robust information management
systems to stay competitive and foster
grow th in the highly volatile g lobal
m a r ke t p l a ce . Tr a n s i t i on i n g qu a l i t y
management systems (QMS) and other
critical systems to the cloud has long-term
benefits if properly implemented.
In a world where manufacturing that
used to be done primarily inside has
been moved to outsourced relationships,
the collaboration between disparate
quality systems that can be enabled by
cloud technologies can increase quality
and compliance. By moving to the cloud,
manufacturers and suppliers have the
ability to connect, interact and integrate
on unprecedented levels. This increased
cooperation and collaboration is fueling
the emergence of a virtual network where
small and large manufacturers alike can
look beyond their four walls to create more
powerful and more efficient means of
ensuring product quality and safety.
Enhanced connectivity allows
internal quality management processes
to unite with quality ecosystem partners,
expanding qualit y b e yond the four
walls of the manufacturers. Integrating
cloud-based systems used by suppliers,
contract manufacturers and distributors
let's manufacturers connect with these
ke y stakeholders quicker and more
directly. It is simply too complex and too
important to relegate those exchanges
to email and fax machines. With this

increased communication, pharmaceutical
manufacturers can respond to risks
earlier. Whenever a product or safety risk
is identified, all involved stakeholders
can start investigations and act faster to
prevent product safety risks from impacting
consumers. Ultimately, this drastically
lowers the risk of recalls. Companies can
avoid the costly financial repercussions of a
recall, while preserving investor confidence
and consumer trust. Greater visibility
and transparency is made possible by
connecting various cloud-based systems,
which leads to safer products.
Future direction
While hesitation around cloud adoption
in the pharmaceutical industr y may
have been justified in the past, current
technologies keep data safe and systems
validated. In many cases, security and
compliance to validation can be increased
by using modern automation techniques.
Au to m a t i o n w i l l re vo l u t i o n i z e t h e
validation process-what used to take
months can be accomplished in days, if
not minutes. IQs and OQs can be run as
often as needed. As PQs move to also be
automated, the entire process can be run
as often as needed, ensuring a continuously
validated system. Cloud monitoring
tools are also being deployed and are on
the lookout for small changes to the
infrastructure that again can be flagged
to reduce risk. The culmination of these
technologies can automatically validate
any updates or changes to cloud-based
solutions, providing life sciences companies
with the confidence of compliance with
FDA and can ensure properly working
systems. Once the industry comes to this
realization, everyone will benefit. Migrating
systems to the cloud dramatically increases
connectivity with key players across the
quality ecosystem and helps all stakeholders
work more collaboratively to create safer
Bruce Kratz, is VP of R&D at Sparta
Systems. Jon Ragati is manager of Global
SaaS Delivery at Sparta Systems.

Clinical trial sites lack accounting resources
Fast reimbursement of trial subjects-a boost to trial participation-is compromised
Clinical trials churn out furious
amounts of data; that's their purpose, after
all. But administering the trial, particularly
for stipends and reimbursements for
patients, are a non-value-added part
of the process. At the same time, trial
administrators and sponsors are under
the gun to be more accountable for trial
Yet many sites have minimal accounting
systems in place. Only 35% of sites use
solutions like a clinical trial management
system (CTMS); most of the rest depend on

paper documentation, spreadsheets and the
like. Sites outside the US are twice as likely
to use a paper system.
In a study conducted with the Society
for Clinical Research Sites (SCRS) and
Greenphire, a vendor of automated
payment systems, 760 sites globally (75% in
the US) were polled during the December
2016-Februar y 2017 period. Results
confirm difficulties in management of
patient reimbursements:
* 63% of sites prefer electronic payments

22 Visit our website at May | June 2017

* More than 75% of sites reported that
reimbursement timelines have an
impact on their ability to pay stipends
and reimbursements to patients
* 44% of sites employ personnel involved
in accounting who also have other
study-related duties
* 74% of sites report that personnel spend
more than 15 minutes per patient visit
on accounting activities.
Greenphire's solution is a cloudbased payment-processing system, which

incorporates payment by pre-paid credit
cards, branded as ClinCard. It is currently in
use by numerous trial administrators.
A further complication of the situation is
that timely payments to investigator sites is
an ongoing concern for trial administrators.
Being able to issue prompt payments to trial
subjects, then documenting the transaction,
enables those administrators to generate
invoices more quickly, speeding up the
overall reimbursement process.

Table of Contents for the Digital Edition of Pharmaceutical Commerce - May/June 2017

Table of Contents
Pharmaceutical Commerce - May/June 2017 - Cover1
Pharmaceutical Commerce - May/June 2017 - Cover2
Pharmaceutical Commerce - May/June 2017 - Table of Contents
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Pharmaceutical Commerce - May/June 2017 - Cover4