In this series we will explore 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.
Any validation project should start with the validation plan. The purpose of the plan is to document the methods, process, deliverables and documentation that will be used during the validation of a system. This makes it a critical document that sets the stage for all subsequent validation documentation and processes.
Lets look at some of the key sections in a validation plan;
Opening the document, this section is used to give the reader a first high level overview of the environment and the approach for the system validation.
Roles and Responsibilities
This section details all the critical roles for the project and is critical in ensuring that the appropriate people review and approve each subsequent document in the validation package.
Now we come to the real technical detail of the document. This section gives the author the opportunity to define the approach to each project specifically. Much more than a simple reference to GAMP5 or other methodology this section contains the specific details of the approach for each system and details which elements of your validation methodology with apply to this project. This is also the ideal section to detail the use of leveraged supplier documentation if that is included in your approach to validation.
To support these sections, others such as; Deliverables, Training and System Acceptance Criteria must be added to give a full view of the validation project.
The validation plan is the anchor of a successful project, from the validation plan all other deliverables and steps in the subsequent validation should be clear and at the end of a project, the validation plan is matched with the Validation Report to confirm that all the tasks deliverables and processes defined in the plan have been completed successfully.
In the next instalment of the series we will look at the User Requirement Specification and the criticality of this key design document.
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.
Read the next blog post in the series here.