Automatic Revalidation

Using Seal's Automated System Validation

In Seal, the system undergoes Automated System Validation, after changes are made. This ensures that any change made to the system is re-validated.

Automated System Validation leverages on Change Controls. It is integrated into the Seal platform software - no changes can be made until a Change control has been performed and approved, ensuring that any change in Seal has no impact on other functionality of the overall system.

Change Controls

How do Change Controls tie in with re-validation?

In GxP companies, Change Control is a structured process used to manage, document, and implement changes in a controlled and systematic manner - this ensures that any modifications have been evaluated for their potential impact on quality and compliance.

Changes to the Seal Platform can disrupt critical functionalities and alter system behaviour. Change control ensures that:

• What is changed in Seal has no impact on other functionality of the system

• To document evidence of tests to show that system functionality is still the same

Having change control built into the Seal Platform ensures that any modifications to the system are documented, reviewed, and have been re-validated - ensuring your platform is consistently at a validated state.