Valid9
Alpha

For GxP software teams

Don’t let compliance be your limiting factor.

From requirements to development, testing and release, keep the work and its evidence together. With matching SOPs, supplier validation evidence and a professional team to help you put it into practice.

Build at the pace of AI. Keep quality in the loop.

Get started for free Create your account and open your own workspace. No sales call.
A traceability matrix: each requirement linked to its task, test, run and release, with gaps flagged Traceability — Access control REQUIREMENT TASK TEST RUN RELEASE Every request needs a verified multi-factor session done ready passed r-0007 Membership is checked on every request; revocation is immediate done ready passed r-0007 Roles limit what people can do, enforced by the server done ready no run — 1 gap in this module A release cannot publish until every selected task has a passing run.
Connected records make missing evidence visible.
A connected lifecycleRequirements, delivery, test evidence and release decisions.
Procedures that match the workSOPs and training alongside the records they support.
A team in your cornerHelp with setup, supplier qualification and your validation approach.

The challenge

Faster development needs a connected quality process.

AI can accelerate the build. Requirements, testing and quality decisions need to keep up.

When the work lives in separate places

  • Requirements, test scripts and sign-offs drift apart.
  • Trace matrices are rebuilt by hand before each release.
  • Gaps surface during audit preparation.

With Valid9

  • Requirements link to development as it happens.
  • Test execution creates a record of results and evidence.
  • Missing links and evidence are visible during the work.

GxP validation, end to end

One lifecycle. Evidence at every phase.

A practical map of the records your validation approach may need. Connect them to the work, from initial assessment through ongoing operation.

  1. 01

    Plan

    Agree the scope and approach.

    • Supplier assessment
    • GxP impact assessment
    • Validation plan
  2. 02

    Specify

    Define what it must do and the risks.

    • User requirements
    • Functional and design specifications
    • Risk assessment
  3. 03

    Build

    Link delivery to requirements.

    • Development tasks
    • Configuration records
    • Code review and unit-test evidence
  4. 04

    Verify

    Test against the specification.

    • Test protocols
    • Executed results and evidence
    • Deviations
  5. 05

    Release

    Review the evidence and decide.

    • Traceability matrix
    • Validation summary
    • SOPs, training and approval
  6. 06

    Operate

    Keep the validated state current.

    • Change control and periodic review
    • Incidents and CAPAs
    • Retirement planning

Across every phase: current risk assessments · traceability · document control · an attributable audit trail

Our principle

The traceability an auditor asks for should come out of doing the work.

Evidence captured along the way, ready to follow from requirement to release.

Traceability that assembles itself

Every task references one requirement. Every run records who executed which test, when, and what actually happened. A release publishes only when its tasks have passing runs against current revisions — then freezes them, so the matrix still says the same thing next year.

Change a requirement or test after it was run, and its runs show as stale. Someone looks at the change, then either affirms with a rationale that the evidence still holds, which a second person reviews, or runs the test again.

Exports to CSV, with the evidence behind each row.

A completed test run showing its executor, time and per-step results Run · Requests without a verified session are refused EXECUTOR colleen@valid9.com COMPLETED 2026-09-22 14:02 UTC RESULT passed 1 · No token expected 401 actual 401 2 · Single factor expected 403 actual 403 mfa_required 3 · Verified session expected served actual served Completed runs are never edited — only corrected, with a reason.

Evidence you can verify, not just trust

Every change is written in the same transaction as its audit record, so a change that cannot be audited is not saved. The trail is hash-chained and anyone in the organization can ask Valid9 to recompute it and name the first broken link.

Review the supplier package with our team to understand the controls and their limits.

An audit trail integrity check reporting a verified hash chain Audit integrity #1229 requirement.updated #1230 run.completed #1231 release.published HEAD 827c778a4765f358f1d163147a9ab6fc… verified 1231 events, no gap, no broken link

Records you can take with you

Export structured records as HTML, JSON and CSV, with file digests and an audit-chain integrity check. Readable without Valid9. Retained source document archives can also be downloaded through the CLI.

Because the question is not whether you can get your data out. It is whether anyone can read it in twenty years.

A record export manifest listing files with SHA-256 digests and a verified chain manifest.json requirements.html sha256 4f2a…c118 test_runs.json sha256 9b07…20de audit_events.csv sha256 c1ed…0bde audit_chain_valid recomputed at export

Work where you work

Connect your assistant. Bring your terminal.

Use the same workspace through Valid9’s MCP server or customer CLI. Read the context, prepare the next change and keep people responsible for quality decisions.

MCP

Your delivery context, in your AI assistant

Connect through browser sign-in. Explore requirements, tests and releases, or authorize draft changes with your existing workspace permissions.

Connect to Valid9 MCP
v9

Your workspace, from the command line

Read records, edit drafts and prepare document imports using your Valid9 account. Start with installation and a few useful commands.

Read the CLI guide

We’ve got your back

The tooling and the process, together.

Bring your requirements and your compliance hurdles. Our team can help you align your SOPs, review supplier evidence and plan validation around your intended use.

Talk with the Valid9 team

Get started for free

Create your account and start organizing your requirements, tests and releases in your own private workspace. Valid9 is in alpha, and your feedback helps shape what we build next.

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