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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.This document contains the system level test cases, based on the functional requirements set forth in the Requirements Specification.If these are separate or maintained as an attachment to the Verification Protocol it makes it easier to add modules or new phases to the validation package while limiting revision time.To ensure that the product actually meets the user’s needs and that the specifications were correct in the first place.In other words, to demonstrate that the product fulfills its intended use when placed in its intended environment.Typically a design specification is not required for a purchased configurable business quality system.In the event that major integration or customization is to be performed as part of the project this document may be added as deemed appropriate by the project team and quality reviewer.
Information such as what work instructions are used to train users to use the system, what system support is available, how the system will be backed up, and how change control will be managed are extremely important elements captured in this document.Your software may be compliant, but you may not be.This article provides answers the top five most common software validation and documentation questions asked by others in FDA regulated industries and demonstrates best practices for meeting the guidelines. The FDA mandates that software used for the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use shall be validated.These documents may be combined so long as you capture all of the information. However, this is more than just a list of functional requirements it also should capture a good description of the various components that make up the system so that everyone has a clear understanding of what this system involves.The Requirements Specification also needs to include information around physical hardware requirements, physical software requirements, client user requirements, training requirements and detail about any customizations or integration with other systems.
This is a required document that can be helpful going forward when a change occurs, as it makes it easier to assess and identify where there is impact.