SOP Computer System Validation
Loading markdown content...
Ready to generate your document?
Talk to usNo commitments required
Use this SOP Computer System Validation template to guide the systematic validation of software and computer systems that impact your medical device quality management system or critical production processes. This document is essential for ensuring regulatory compliance (such as ISO 13485, GAMP5, 21 CFR Part 11, MDR/IVDR) and should be completed whenever new software is implemented, updated, or decommissioned to document risk-based validation planning, testing, deployment, maintenance, and retirement activities. Proper use of this SOP helps maintain data integrity, product safety, and continuous regulatory compliance throughout your software lifecycle.