AgosIT Documentation Series

Supporting Documents

In this series we have explored the documentation required to successfully deliver and record a Computer System Validation (CSV) project.

For GxP systems it is necessary to establish a series of documentation to record the approach and execution of validation. The documents in this series are based on a GAMP5 approach to a Category 4 – Configured Product.

System Access Plan

A System Access Plan is used to record the structure and distribution of access rights within a system. Often displayed as a matrix details of each individual access right, its function and which roles are assigned the right are recorded. In addition to the list of roles and rights, a list of individual users assigned to each role is recorded.

This document remains live and is updated as access is modified throughout the system lifecycle. This document is critical in regulatory inspections as it shows in a clear and immediate way the distribution of access in the system. Being able to demonstrate control of access and rights contributes to compliance with Data Integrity regulations such as FDA 21 CFR Part 11.

Requirements Traceability Matrix

A requirements Traceability Matrix or RTM is key to the validation process. This document tracks all requirements and provides a reference detailing where the Design, Installation, Operational and Performance testing has been completed for each requirement. This is often included in the Validation Report or can be provided as a standalone document.

Auditors will often look at the Validation Report and specifically the RTM as a first step in determining the compliance of a validated system.

Summary

This article completes the series on validation documentation to see any of the previous articles in the series visit, https://agosit.com/news and search for the “Documentation Series

For further support and guidance with any aspect of your validation project, from full project delivery to individual documentation support, please reach out to us at AgosIT at qualityservices@agosit.com.

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