Establish and Document the Application's GxP and Regulatory Validation When Required

This chapter explains how to establish and document formal validation for Applications subject to GxP or other regulations that require it.

When Regulatory Validation Is Required

In regulated industries such as life sciences, Applications that support regulated activities, for example manufacturing, clinical trials, laboratory work, or quality management, must often be formally validated to demonstrate that they consistently do what they are intended to do. GxP, the family of “good practice” regulations, is the most common example, but other regulations impose similar obligations. The Application’s regulatory classification determines whether validation is required.

Establish Regulatory Validation

For Applications that require it, establish, with Quality Assurance and Risk and Compliance, the validation approach and plan, the requirements and risk assessments on which validation is based, the validation testing and its evidence, the controlled documents and their approval workflows, how changes are assessed for their impact on the validated state, and how periodic reviews confirm that the Application remains in a validated state.

Document and Share Regulatory Validation

Record the validation plan, evidence, approvals, and validated-state status in the Application Documentation, using formal approval workflows for controlled documents where regulations require them, as permitted by the documentation guardrails. Retain validation records for the period regulations require.

Best Practice: Establish and Document the Application’s GxP and Regulatory Validation When Required

It is a best practice to both establish and document the solution for regulatory validation where an Application’s classification requires it: define and execute a validation approach with Quality Assurance and Risk and Compliance, control changes against the validated state, and retain controlled validation records.

Benefits: Documented validation demonstrates to regulators that regulated Applications are fit for their intended use, avoiding findings that can halt operations. Controlling changes against the validated state keeps the Application compliant through every Release, not only at initial deployment.

Connections to Related IF4IT Practices and Inventories

The GxP Compliance Framework describes GxP obligations and practices in detail. The Regulatory Agencies Inventory and Attributes describes the regulatory bodies that impose validation requirements.