GMP – SOP – Computerised System Validation and Assurance (CSV / CSA) Governance SOP
CSV/CSA SOP and templates.
5 500 Skr
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Purpose:
This SOP defines the governance, responsibilities, and lifecycle controls for Computerised System Validation (CSV) and Computerised System Assurance (CSA) to ensure that GMP-regulated computerised systems are fit for intended use and maintain data integrity.
Regulatory Alignment:
EU GMP requirements for computerised systems, including principles aligned with EU GMP Annex 11, EU GMP Annex 15, and current risk-based validation and assurance expectations.
Included Files:
• SOP – Computerised System Validation and Assurance (CSV / CSA) Governance
• Computerised system inventory and risk classification template
• Validation and assurance lifecycle overview
Format:
Microsoft Word (fully editable)
Intended Users:
Pharmaceutical manufacturers, marketing authorisation holders, IT and validation teams, system owners, and quality assurance personnel responsible for governance of GMP-regulated computerised systems.