GxPValidate help¶
GxPValidate runs a computerised-system validation from the Validation Plan to the Validation Summary Report. It follows GAMP 5 and FDA Computer Software Assurance (CSA): the assurance effort for each requirement is proportionate to its risk.
Start here¶
- Getting started: create your organization, invite people and validate your first system.
- The validation lifecycle: which documents exist, in what order, and who signs them.
- Electronic signatures: how signing and re-authentication work.
Guides¶
| Topic | What it covers |
|---|---|
| Organization and users | Roles, invitations, session timeout |
| Single sign-on | OIDC and SAML with Entra ID, Okta and Google Workspace |
| Systems and roles | Creating a system, per-system roles |
| Risk assessment | System risk and requirement tiers |
| Requirements | URS, FS, DS, IS, tracing, the library |
| Test cases | Automated, scripted manual and unscripted tests |
| Executions | Running tests and attaching evidence |
| Automated runs | Running pytest-gxp suites in Docker per environment |
| Deviations | Raising, investigating and closing deviations |
| Traceability matrix | The live RTM and its gap codes |
| AI assistants (MCP) | Connecting an assistant to edit drafts |
| Billing | Trial, plans and invoices |
| Changelog | What changed and when |