Validation

Computer System Validation
Computer System Validation 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.

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

  • Validation Strategy
  • Validation Plans
  • Risk Assessment
  • Functional and User Acceptance Test (UAT)
  • Unit Test (UT) / System Integration Test (SIT) Protocol and Report
  • Code Review Report
  • 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) and Remarks
  • Standard Changes (Security patches, Hotfixes)
  • System- and Data Corrections

Systems Validation Experience
Oracle Clinical/TMS: Installation, Upgrades, System Corrections, Releases, Patches
Validation- and Derivation Procedures, Batch Data Loading, Performance, Customized Reports, SQL scripts, Interfaces etc.

Test Tools Experience
8+ 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.

Document Management Systems Experience
10+ years experience in using Document Management Systems.

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.