Validating a single system can take the better part of a year
A GxP regulated system needs documented evidence that it works as intended, and that evidence has to stand up to an audit. When the work is handled manually, it can be slow — specifications, test scripts, traceability, and reporting all assembled by hand, and every subsequent change reopens some of that work.
GxPForge is SequoiaAT's platform for computer system validation in life sciences, built around that recurring cost.
Validation records spread across files, spreadsheets, and scanned PDFs.
Traceability that has to be maintained manually and can easily become incomplete.
Legacy records that are hard to search and difficult to manage safely during a system migration.
Revalidation effort that does not scale with risk, because the tooling cannot tell high risk functions from low risk ones.
The other work around GxPForge
The platform is part of a broader service that includes GxP document migration and validation support, moving legacy validation documentation into a system that keeps it current, searchable, and auditable rather than static and stale, and test automation that generates the verification evidence validation depends on.
This follows the risk based approach in GAMP 5: put more effort into higher risk areas and avoid documentation that does not add useful control.
Quality, validation, and IT teams in pharma, biotech, and medical device companies responsible for keeping GxP systems compliant — particularly those facing a system migration, a growing estate of validated systems, or an audit finding on validation documentation.
This page stays at the level the public material supports. Specific GxPForge features, workflows, and the compliance frameworks it targets should be added once provided.