Overview
Seal’s validation methodology represents a new paradigm for GxP compliance. It is built from the ground up on the principles of GAMP 5 2nd Edition and the FDA’s 2022 CSA Guidelines, enabling regulated companies to break free from the slow, burdensome documentation of legacy systems. This modern, risk-based approach allows you to move faster and with greater confidence, focusing on critical thinking and patient safety over paperwork. We partner with our customers to ensure compliance is not just a checkbox — but a foundation for quality.CSV vs CSA: Key differences
Computerized System Validation (CSV) is a traditional, compliance-focused method that often results in a heavy documentation burden and scripted, repetitive testing, making it a slow and burdensome process. Computerized System Assurance (CSA) on the other hand, is the modern quality- and risk-focused approach. CSA uses fit-for-purpose evidence and risk-based testing to maximise efficiency. Instead of asking “did we produce all the documents?”, CSA asks “does the system do what it’s supposed to do, and have we focused our testing on the areas of highest risk?”. This approach ensures the system is correctly installed, operates as expected, and performs reliably for its intended use, without the legacy overhead.Accelerating compliance with AI (Beta)
A core principle of Computer System Assurance (CSA) is to leverage automation to reduce manual effort and allow teams to focus on critical thinking. Seal’s integrated AI capabilities are a key enabler of this principle. While a human must always be the final reviewer and approver for any GxP record, our AI assistants can significantly accelerate the creation of compliance documentation.Autofilling documentation
Our AI can be configured to assist in filling out routine but essential paperwork. For example, when initiating a change, the AI can pre-populate large sections of a Change Control form or a Risk Assessment document based on the context of the proposed changes. The responsible personnel then simply needs to review, edit, and approve the AI-generated draft, dramatically reducing the time spent on manual data entry.Drafting new validation tests
For significant configuration changes, new validation tests are often required. Seal’s AI can analyze the changes made in a Change Set and automatically draft new, relevant test scripts. These scripts can then be reviewed, refined, and added to your automated validation suite, ensuring that your testing keeps pace with the evolution of your system.Evolving in a validated state
A core principle of the Seal platform is its ability to evolve without compromising its validated state. This is enabled by our powerful scripting engine and our Change Sets feature, which provides a formal, auditable mechanism for reviewing and approving all proposed configuration changes. This means you can continuously improve your processes—adding new fields, updating workflows, or changing permissions—with a full audit trail and formal sign-off. By combining this with custom automated validation tests written in our scripting engine, you can ensure that your unique processes continue to work as intended after any change. This combination of controlled change management and tailored automated testing allows your system to remain in a continuously validated state as it adapts to your business.Risk assessments
A risk-based approach is at the heart of modern Computer System Assurance (CSA) and is fundamental to Seal’s methodology. We provide configurable templates and a clear framework for you to conduct and document your risk assessment, focusing your validation efforts on the areas of highest impact to patient safety and product quality.User requirement specification
A URS is a documented set of user requirements, specific to the customer’s configuration. A well-constructed URS ensures traceability, supports effective risk assessment, and provides a rational basis for determining the scope and depth of testing required.Functional specification
Functional Specification is a document defining how the platform is expected to work from a functional point of view. A good FS should include:- Descriptions of core features and what each one does
- Rules and logic applied (e.g. automated triggers, validation constraints)
- User groups and permissions
- Field-level behaviour: inputs, outputs, and data flows
- Configurable settings: options, or flags
Traceability matrix
A traceability matrix maps user requirements from the URS onto functions from the FS. The matrix should demonstrate how each user requirement will be met, and also give an indication as to how suitable the relevant function is to meet said requirement.Process and timeline
Step 1 - Alignment on VMP (Validation Master Plan) Step 2 - Complete URS, FS, and Risk Assessment Step 3 - Complete configuration Step 4 - Identify required manual and automated configuration tests based on risk-assessment. Develop automated configuration tests Step 5 - Run manual and automated configuration tests and document reporting. Step 6 - Setup continuous monitoring & compliance reviews. Define re-validation criteria. Seal’s implementation team supports each step to ensure a smooth, efficient validation process tailored to your organization.Validation summary
To summarize, Seal achieves compliance by using guidelines from GAMP 5 2nd edition, embracing a risk-based approach to maximise efficiency, avoid unnecessary burdens, and focus validation efforts where they matter the most. Our approach addresses validation from two key angles:- The platform - validated by Seal via a SDLC, thorough testing and collaboration with users on any major platform updates
- The configuration - validated collaboratively with each customer, using templates from Seal to reflect their specific use case.
- Validation Master Plan template
- Risk Assessment template
- User Requirement Specification template
- Functional Specification template
- Traceability matrix template
- Change Control template
- Automated configuration validation guide