Computer System Validation

Computer System Validation (CSV) of IT systems used in the pharmaceutical industry is a critical, complex, and time consuming task. There are regulatory as well as practical business considerations that must be addressed when validating a computer system.

Validation Services | Testing of GxP Systems

In most projects we work with the customer based on their QMS system, validation protocols and templates and QMS system. We can assist your company in the following validation areas:

• Validation Strategy
• Validation Plans
• Risk Assessment
• Functional and User Acceptance Tests (UAT)
• IQ/OQ/PQ Protocols
• Writing Test Cases
• Test Execution
• Defects Management
• Data Review
• Validation Summary Reports (IQR/OQR/PQR)
• 21 CFR 11 System Evaluation
• Standard Operating Procedures (SOP) development
• Release Management
• Change Management
• NC Handling (Non-conformity)
• Standard Changes (Security patches, hotfixes)
• System- and Data Corrections

Systems Validation Experience

• Oracle Clinical/TMS/RDC:
  • Installation, Upgrades, System Corrections, Releases, Patches
  • Validation- and Derivation Procedures
  • Customized Reports
  • SQL scripts

Test Tools Experience

6+ years experience using TIMS (Test Information Management System), more specifically the software TestDirector by Mercury Interactive Corporation. TestDirector was later acquired by HP (Hewlett-Packard) and renamed to HP TestDirector. TestDirector is now HP Quality Center software - a premier Quality Management solution for Software QA Professionals.

• TestDirector (also referred to as "TIMS")

Link to data sheet for TestDirector (HP Quality Center software)

Document Management Systems Experience

10+ years experience in using Document Management Systems.

• Documentum

Documentum is document management software that provides management of document content and attributes such as check-in, check-out, workflow, and version management. The Documentum product is a three-tier, client-server system built on top of a relational database.

• Documentum on Wikipedia
• Documentúm on vendor EMC website

V-Model

The V-Model is a systems development model designed to simplify the understanding of the complexity associated with developing systems. Read more...

What is GxP?

GxP is a general term for Good Practice quality guidelines and regulations where the "x" can be C for Good Clinical Practice, L for Good Laboratory Practice, M for Good Manufacturing Practice, etc. Read more...

21 CFR Part 11

Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records. Read more...