QA028: Computer System Validation (CSV)
OBJECTIVE: This SOP shall define the system for planning, executing, documenting and maintaining validation of GxP-relevant computerized systems in accordance with EU-GMP Annex 11 and Annex 15. This SOP shall ensure that computerized systems consistently perform as intended, protect data integrity, and do not adversely affect product quality or patient safety. SCOPE: This procedure shall […]