Understanding Validation Plan Deliverables
Before a new system can go into use, it must be validated to ensure that it consistently performs to regulatory standards of quality and accuracy. A Validation Plan (VP) outlines the approach, resources, and activities necessary to achieve this, ensuring that products, processes, and systems meet all required regulatory specifications and standards. It also describes documentation deliverables that catalog the progress and evidence of the validation effort, providing a record of the final qualification of the system.
When reviewing a VP, here are some of the typical VP deliverables you may encounter:
User Requirements Specifications (URS) defines how the system is intended to be used.
Configuration Specification (CS) includes system configurations such as values for the dropdown lists or the workflows that each document folder would follow.
Functional Requirements Specification (FRS) defines the operations and activities the system must perform.
Technical Design Specification (DS) defines how the system does the activities described in the FRS.
Traceability Matrix traces the requirements to the test scripts.
Integration/Migration Specification (if an integration or migration is included in the validation plan) details how the data is moving and the testing approach for the migration accuracy.
Installation Qualification (IQ) confirms that the hardware or software components have been installed and configured according to the vendor specifications.
Operational Qualification (OQ) verifies that the equipment performs within the vendor’s parameters for each function defined in the URS. This includes testing full operating range and failure modes within a realistic operating environment.
Performance Qualification (PQ)/User Acceptance Testing (UAT) confirms the system meets the intended use of the sponsor, testing full operational processes and business use cases.
Validation Summary Report is published once the validation effort is completed and summarizes the entire validation effort (scope, test cases, deviations, etc.)
System Release Memo records the date on which the system is released into production. It should be published following the Validation Summary Report.
In highly- regulated and quality-focused organizations, VP deliverables such as these are necessary to demonstrate that new systems will perform as needed. Each deliverable plays a critical role in guiding the validation process and demonstrating that the necessary standards have been met.