SOFTWARE VALIDATION SERVICE

Clinical Systems offers Software Validation Services for the FDA regulated pharmaceutical industry. Our knowledge of industry practices and standards along with regulatory requirements, enable us to create practical and cost-effective solutions for your validation needs.

We have been performing computer systems validation for over 20 years. This experience with the validation process ensures that your system is thoroughly tested and documented.

Our Software Validation Service follows a lifecycle methodology. A series of documents is generated to demonstrate that the system is performing according to specifications. We can assist you in all phases of the validation process, from the development of the validation master plan to the user acceptance phase.

Clinical Systems can supply skilled individuals and manage project teams to meet your validation requirements. Validation services include but are not limited to:

  • Project Management
  • Validation Master Plan
  • User Requirements & Specification
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Traceability Matrix / Summary Report
  • 21 CFR Part 11 Assessments
  • Auditing Services
  • Design & Development of Procedures

Please Contact Us to discuss your Software Validation needs.