CTE performs FDA
validation for a pharmaceutical company
This
customer is a research-based pharmaceutical
company dedicated to treating and preventing
human disease. Their drug development program
has yielded an extensive portfolio of pharmaceutical
compound candidates.
Challenges In general, the pharmaceutical
industry is defining their business objectives
to maximize their probability of success
due to intense pressure to increase productivity
and make research and development (R&D)
more efficient. They must innovate faster,
reduce risk, and increase profitability.
Companies face discovery and development
cycles that often total 7 to 10 years, and
development costs approaching US$800 million
for each new drug.
The customer was looking for a partner who
could help them implementing enterprise
applications with scripting and validating
master plan for the operational qualification
to reduce risk.
Solution
The customer was attracted by CTE’s
ability to supply scripts and templates
for the Operational Qualification (OQ),
and OPM knowledge for the creation of the
Validation Master Plan, User Requirements,
and Functional Specifications.
CTE
was selected do to:
Extensive experience
in FDA validation in the OPM Environment
CTE comprehensive
set of Validation Test Scripts
114 OPM Unit Test
Scripts combined with business scenarios
and process flows for system validation.
These scripts are
modified and augmented to support the
implementation and create company specific
Standard Operating Procedures in a GMP
and Part 11 compliant environment.
Assistance meeting
requirements for Operational Qualification
(OQ), Installation Qualification (IQ)
and Performance Qualification (PQ).
In addition, CTE have been able to provide
guidance in the design of the Performance
Qualification.
