OPA Validating
(Oracle® Pharmaceutical Applications)

We thoroughly validate Oracle® Pharmaceutical Applications (OPA) installations. We have performed validation services for some of the largest biotechnology and medical device companies in the world, as well as some of the smallest.

Our services cover:

• Oracle® Clinical
• Oracle® TMS
• Oracle® RDC, including site qualification and training
• Oracle® AERS

We offer the full suite of validation documents:

• Validation Plan
• Requirements
• Traceability
• IQ/OQ/PQ Protocols

We offer validation tests for all OPA products:

• Functional
• User Acceptance
• 21 CFR Part 11
• Stress

Our management of the validation process has been successful at large and small pharmaceutical, biotechnology, medical device, and CRO companies. Our combined expertise in regulatory issues, as well as our detailed understanding of the data management system’s functionality make our documents different. Our deliverables, which are based on the standard functionality of systems, are customized to each client’s specific needs.