Contact | Careers

Client Case Studies

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.

Benefits

  • Streamlined process
  • Enhanced performance
  • Reduced risk

For more information, please visit www.ctepl.com or e-mail us at info@ctepl.com.
Back
Clients

CTE CMMI Level 5 Certified