Even if you have the expertise in-house, validation activities often divert the efforts of your key personnel from their core business responsibilities. Our computer systems validation (CSV) specialists will take full responsibility for executing every phase of your validation project, from writing the Validation Plan to delivering the final Summary Report, with minimal support from your employees. Our validation methodology incorporates the FDA's latest guidance for employing a risk-based approach to product quality regulation. This approach allows us to:
- Write more efficient test cases with fewer steps
- Place greater emphasis on testing critical functions
- With risk-based justifications, minimize testing of secondary functions
We at Triligent also understand that documentation is at the heart of every validation project. During an FDA audit, you may be called upon to defend a validation effort that took place several years earlier, without the assistance of the author. Triligent's clearly written, well-organized documentation will make defending that validation effort easier and will prompt fewer inquiries by the auditor.
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