Validation

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Why Seal is different

Traditional GxP systems are frozen after validation. Any change risks triggering months of re-validation work. Teams are forced to choose between compliance and improvement—a fundamental conflict between the goals of quality and the operational needs of the business. Seal resolves this. Unlike systems that must be locked down after validation, Seal is built so that every change goes through Change Sets with formal review and approval, and automated tests verify the system after every change. You evolve your configuration without compromising your validated state. Pharmaceutical, biotech, and medical device companies run their GxP-regulated operations on Seal—GMP manufacturing, GLP laboratories, GCP clinical trials. Customers run their entire QMS on Seal: document control, deviations, CAPAs, change control.

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Our approach to validation

Audit trails, access controls, e-signatures, version integrity, and continuous automated testing are validated and running from day one. The platform does the heavy lifting — your validation effort goes entirely into the configuration and workflows that are unique to your operation. A field that calculates a batch yield gets rigorous testing. A field that stores a project description does not. Friction is not rigor. Less documentation theatre.

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Risk-based validation

Software validation is the process of ensuring and documenting that a system is fit for its intended use. The level of formality scales with risk—early R&D needs lightweight documentation, GMP manufacturing requires formal compliance evidence. Most customers fall into one of two categories: If you’re somewhere in between—process development, scale-up, or characterization work—we’ll tailor the approach to your risk profile during implementation.

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Platform testing

Seal runs automated tests daily—unit tests, integration tests, and end-to-end tests—covering functionality, stability, and reliability. These verify the platform operates as intended and maintains its validated status across its lifecycle. Once live, you can view all platform test results in the Validation tab. This applies to all customers regardless of pathway. For testing your specific configuration, see Staying validated.

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Non-GxP: User Acceptance Testing

For non-GxP systems (early-stage R&D, non-regulated workflows), the goal is to ensure and document that Seal is fit for your intended purpose. This is achieved through a lightweight UAT process. Your responsibilities:

1. Define requirements — outline the specific configurations and workflows you need
2. Perform UAT — test against your real-world use cases to confirm Seal is configured correctly
3. Document acceptance — sign off on a summary report confirming fitness for purpose

We provide templates and scope the UAT plan with you. Most non-GxP validations complete in days.

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GxP validation

For GxP systems (GMP, GLP, GCP), a formal validation process is required. We handle the heavy lifting—you review and approve.

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Our approach

Seal’s validation methodology is built on GAMP 5 2nd Edition and the FDA’s 2022 CSA Guidelines, informed by consultation with an author of GAMP 5 2nd Edition.

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GAMP 5 software categories

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Seal is a Category 4 system

Seal is a GAMP 5 Category 4 (Configured Product). You configure standard, vendor-tested features — workflows, templates, fields, approval chains, permissions — to match your business processes. Seal validates the platform; you validate your configuration. Modules are standard blueprints. Seal’s modules — ELN, Inventory, Samples, QMS, and others — are standard blueprints available to every customer, pre-tested and validated across multiple regulated customers. Automations handle routine field logic — setting record IDs, populating fields, generating labels, enforcing validation rules. Each automation reads and writes fields on the entity it belongs to, using Python syntax for readability. Seal analyses the code at save time and only allows writes to fields the automation explicitly references.

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CSV vs CSA

Seal follows CSA (Computerized System Assurance) — the modern, risk-focused alternative to traditional CSV, endorsed by the FDA. CSA asks “does the system do what it’s supposed to do?” rather than “did we produce all the documents?”.

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Your responsibilities

1. Define requirements — provide your URS, relevant SOPs, and specify regulatory standards (21 CFR Part 11, EU Annex 11, etc.)
2. Risk assessment — participate in identifying high-risk areas for patient safety, product quality, and data integrity
3. Review and approval — review key validation documents (VMP, validation report) and participate in formal UAT

We guide you through each step and provide all templates.

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Process and timeline

Our implementation team drives each step:

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What you get

Every Seal customer receives our validation template pack:

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Staying validated

Once validated, how do you stay validated as your system evolves? Two mechanisms work together:

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Change control

All modifications—configuration, data, workflows—go through Change Sets with formal review and approval. Before any change goes live:

1. Impact assessment — the system shows exactly what will change
2. Review and approval — designated reviewers sign off electronically
3. Audit trail — every change is logged with who, what, when, and why
4. Automated tests — configuration tests run to verify nothing broke

This means you can continuously improve—add fields, update workflows, change permissions—without breaking your validated state. Every change has documented justification and approval.

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Continuous testing

Seal can generate and execute User Acceptance Tests for your configured workflows. Tests are written in natural language (e.g., “Create a Batch Record from the Production template and verify all required fields appear”), reviewed and approved by your team. Seal executes them automatically, recording video and system events as audit evidence. When tests run:

• Every platform release — your test suite runs automatically before your team uses a new Seal version
• After configuration changes — verify workflows still work after you modify templates, fields, or approval chains
• On demand — trigger tests manually whenever you need assurance

Bonus: training videos. The same tests can generate up-to-date training recordings automatically whenever your configuration changes—no manual screen recording needed. See Release process for details on risk levels, notification policies, and how automated testing works.

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Frequently asked questions