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The specific validation process you follow depends on the intended use of your system. Seal supports two distinct, risk-based pathways to ensure your platform is fit for purpose.

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Two pathways for validation

For a high-level overview of our validation philosophy, please see the Validation overview.

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How is my system validated?

The process for validating your Seal instance depends on your intended use. All validation starts with Baseline Validation, which is performed by Seal. After that, the path diverges depending on whether you are in a GxP or non-GxP environment.
In Seal, automated, baseline validation tests are performed daily to ensure the functionality, stability, and reliability of the Seal Platform. These automated tests ensure that it consistently operates as intended and maintains its validated status across its life cycle.A full list of all tests can be found in the Validation tab in the bottom left of your Seal platform screen.
For non-GxP systems, the goal is to ensure and document that Seal is fit for your intended purpose. This is achieved through a lightweight User Acceptance Testing (UAT) process.

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Your responsibilities

Your primary responsibility is to define what you need the system to do and to confirm it does it. This typically involves:
  1. Defining Requirements: Outlining the specific configurations and workflows you need.
  2. Performing UAT: You and your team conduct tests based on your real-world use cases to confirm that Seal is configured correctly.
  3. Documenting Acceptance: Signing off on a simple summary report that confirms the system is fit for purpose.
Our team is here to help you scope a U-AT plan and provide templates to make this process as simple as possible. This approach is much faster and more efficient than a formal GxP validation process.
For GxP (including GMP and GCP) systems, a more formal validation process is required to ensure compliance with regulatory standards. This is a collaborative effort between your team and the Seal Team.

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Your responsibilities

While we do the bulk of the work, your active participation is crucial. Your responsibilities include:
  1. Defining Requirements: Providing your User Requirement Specifications (URS), any relevant internal SOPs for validation, and specifying which regulatory standards (e.g., 21 CFR Part 11) you operate under.
  2. Risk Assessment: Participating in the risk assessment process to identify high-risk areas of the configuration that could impact patient safety, product quality, or data integrity.
  3. Review and Approval: Reviewing and approving key validation documents, including the Validation Master Plan (VMP), and participating in User Acceptance Testing (UAT) as part of the formal qualification process.

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The GxP validation process

Our experts will guide you through a structured validation process that includes:
  1. Risk Assessment: Using Seal’s provided templates and framework, we partner with you to conduct a systematic risk assessment to identify, evaluate, and mitigate risks associated with your configured system.
  2. Validation Master Plan (VMP): Outlining the overall validation strategy, scope, resources, and deliverables.
  3. Risk-Based Qualification and Testing: Performing and documenting formal, risk-based tests to verify that the system is installed correctly, operates as expected, and performs reliably for your intended use. This includes formal UAT.
  4. Validation Report: A final report that summarizes the validation activities and confirms that the system meets all specified requirements.
  5. Compliance Validation: Ensuring and documenting that the system meets the requirements of all applicable regulatory standards.

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Automatic revalidation

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 Control. It is integrated into the Seal platform software using Change Sets - no changes can be made until a Change Set has been performed and approved, ensuring that any change in Seal has no impact on other functionality of the overall system. The Change Set is the mechanism that enables the principle of continuous validation in a dynamic system.
Learn more about Change Control and Change Sets here.
How do Change Sets enable revalidation?A core principle of GxP is that all changes must be managed through a structured, auditable process to ensure they don’t negatively impact quality or compliance. Seal’s Change Set feature is the direct implementation of this principle.By requiring all modifications—from data to system configuration—to go through a formal Change Set with pre-defined review and approval steps, Seal ensures that:
  • The full impact of a change is assessed before it goes live.
  • An electronic, auditable record of the review and approval is automatically created.
  • The system is always maintained in a validated state.
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