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Expedited Validation Process
PSC has developed template validation documentation, as well as generic company-wide SOPs and policies which can apply to a broad range of validation efforts. When assisting clients in their validation efforts, we start with this library of template documents, then customize them to each company's specific needs. The result is a well-ordered and significantly accelerated validation process.
The following are some of the templates that have been developed:
- Requirements specifications (functional, Part 11, operational, usability)
- Validation plans
- 21 CFR Part 11 gap analysis sheets
- IQ/OQ/PQ protocols
- Traceability matrices
- Validation final reports
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