The CSV/CSA approach (GAMP 5/SDLC) places emphasis on system deployments in highly regulated (FDA/MHRA/Eudralex) GxP environments, utilizing the current risk
based approach with regards to testing approach, data integrity, system security, access control, configuration management and audit trail requirements, ensuring regulated compliance and that ‘the
validated system performs as designed and intended.’
CSV/CSA Activities
Completion of risk assessments (FMEA, 5 Whys, Fault Tree Analysis) to:
Ensure compliance of regulatory requirements (FDA/MHRA/Eudralex) relating to code of Federal Regulation, CFR
Title 21:
- Part 11, Electronic Records/Electronic Signatures
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Part 210, cGMP in Manufacturing, Processing & Packaging
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Part 211, cGMP for Finished Pharmaceuticals
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Part 820, Quality System Regulation
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Part 860, Medical Device Classification
Eudralex Volume 4:
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Annex 1, Manufacture of Sterile Medicinal Products
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Annex 11, Computerised Systems
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Annex 15, Qualification and Validation