Quality management for the teams building the software.
Requirements, delivery, test execution, release traceability and an attributable audit trail — in one place, for teams working under GxP expectations.
Valid9 is in alpha. We are looking for a small number of partners to build it with, not customers to sell it to yet.
Become an alpha partnerWhat it does today
Requirements
Grouped into modules, with acceptance criteria, discussion and attachments. Every delivery task references one.
Test execution
One canonical test per requirement, with ordered steps. A run records who executed it, when, and what actually happened — and becomes immutable once complete.
Releases that check themselves
A release publishes only when its tasks have passing runs against the current revision. Publishing freezes the requirement, task, test and run, and produces a traceability matrix you can export.
Reviews bound to a version
A review decision binds to one saved revision and a SHA-256 digest of it, so nobody can quietly edit what was reviewed.
An audit trail that can be checked
Every change is attributable and time-stamped, written in the same transaction as the change itself, and hash-chained so the trail can be verified rather than trusted.
Records you can take with you
A complete export of an organization's records as HTML, JSON and CSV, with a digest per file — readable without Valid9, in twenty years.
What it does not do yet
If you evaluate software for regulated use, you already know to ask this question, and you already know what a vague answer means.
- No qualified electronic signatures. Reviews are version-bound decisions with a digest. They are not signatures under 21 CFR Part 11, and we do not describe them as such.
- Documents are drafts. SOPs, risk assessments and protocols are register entries. There is no approved or effective state yet.
- Valid9 is not yet validated for its intended use. The work is underway and is not finished.
- Evidence files attach to requirement discussions; a test run cannot yet carry one.
We keep a written supplier package — intended use, control mapping, supplier register and a gap register that lists the above and more, with what is planned for each. Alpha partners get it in full, early.
Become an alpha partner
What that means in practice: you get the product and the supplier package early, you tell us where it fails your process, and we build against that. Expect rough edges and direct access to the people fixing them.