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Validatingcomputerisedsystem com

These documents may be combined so long as you capture all of the information.

Why Can’t I Just Purchase Validation Documentation?

What Documentation Is Required For Regulatory Validation?

The following documents are what auditors like to see in a Quality System Validation: Software Validation Protocol; Network Diagram; Software Requirements Specification; Risk Analysis (the GAMP standard template is recommended); Part 11 Compliance Analysis; Design Specification (only for systems or areas of the system which contain custom code such as integrations between your Product Lifecycle Management (PLM) and Enterprise Resource Planning (ERP) systems) ; Test Plan; Test Specifications/Test Cases; and a Final Validation Report.

Everyone’s business is a little different so software manufacturers such as Omnify Software have developed highly configurable systems that can be set up to manage your business processes electronically.