Optimation's validation team has experience validating both Optimation-supplied systems and systems designed and provided by others. Our validation services apply custom tools and methods to produce the necessary validation deliverables. Selection of validation personnel ensures objectivity and impartiality; validation services are organized as an independent entity to those designing and developing the system. Subject matter experts within Optimation can provide consulting to other systems and software providers regarding validation requirements and regulations, such as 21 CFR Part 11 requirements for electronic records and electronic signatures.
Optimation validation applies a methodology developed consistent with the principles of GAMP5. Using Optimation’s methodology, Validation project teams plan validation activities, specify the system, write system tests, and perform those test both at Optimation and at our customer facilities. Optimation has experience applying the Optimation methodology, the customer methodology, or a merger of the two.
Validation Deliverables and Templates
Project deliverables vary depending on project requirements, however, the validation staff has the knowledge and experience, as well as templates and samples, to develop the following validation deliverables:
- Validation Master Plan (VMP)
- Risk Assessment (RA)
- User Requirements Specification (URS)
- Functional Specification (FS)
- Design Specification or Detailed Design Specification (DS or DDS)
- Traceability Matrix (TM)
- Factory Acceptance Test (FAT)
- Site Acceptance Test (SAT)
- Installation, Operational, and Performance Qualifications (IQ, OQ, PQ)
- Test Summary Report (SR)
Optimation’s typical validation projects include the documents and activities listed below. Documents can be produced using customer templates or Optimation templates. Optimation templates can be modified to meet customer requirements as needed.
- Validation Plans and Risk Assessments
- URS, FS, DS, and Traceability Matrix writing
- FAT, SAT, IQ, and OQ writing and test execution
- Test / protocol summary report writing
Validation Methods and Tools
Optimation has developed unique methods and tools to effectively deliver validation projects. We have specification templates that use a table-based format to document discrete information and align with our test writing tool. A custom specification-to-test plan transition tool builds test plans from specifications, using macro automation to speed up repeated tasks and minimize protocol errors. A custom test / protocol execution tool tracks progress based on items completed, automatically estimates completion dates, and provides other data to manage testing, including schedule and resources.