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General

If your system doesn’t have a direct GxP impact (for example, it’s used for early-stage R&D), you don’t need to follow the formal Configuration & Compliance Validation process. Instead, you can rely on the much simpler process of User Acceptance Testing (UAT) to confirm the system is fit for your purpose.
Seal has automated a large portion of the validation process. Most validations complete in days, not months. Contact us for a specific estimate based on your configuration.
This depends on your implementation timelines and when you want to start using various modules in Seal.Validate when implementation is complete—with everything built and configured. For larger implementations, we also support phased validation where individual workflows are validated as they go live.
During implementation, we’ll discuss which regulatory standards you need to comply with (e.g., 21 CFR Part 11, EU Annex 11) and ensure the correct validation approach is applied.
Yes. Seal’s validation documentation and templates can be adapted to fit your QMS.

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Revalidation

Seal provides baseline validation testing for all customers. You don’t need to repeat these tests.Additional testing may be required for your specific configurations and workflows. Contact us to scope this together.
Changes to your platform require revalidation. Seal’s automated validation runs continuously—when changes are made through Change Sets, the system automatically re-validates to ensure continued compliance.
Yes, template and workflow changes require validation. Seal’s Change Set process handles this automatically—changes go through formal review and approval, and automated tests verify the system remains in a validated state.
No. There is no change to server locations, databases, or core system architecture when your organisation moves. Our Customer Success team can support any risk assessments you need.

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Documentation

Yes. We provide a comprehensive validation package including templates for URS and Risk Assessment, platform validation documentation, and a Validation Summary Report you can generate on-demand.
Yes. We provide baseline UATs that you can use as a starting point for testing your specific configuration.
Yes. You can generate and download a Validation Summary Report directly from the Seal platform.

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Other questions

The current version number is visible in your organisation’s Settings page.
No. Disabled features have no interaction with your platform and don’t require validation.
The API enables data flow but does not change platform behaviour. You are responsible for documenting your API configuration and risk assessment. The API itself is tested as part of Seal’s routine testing.