Validation, without the binder theater.
Each organization starts as a blank slate, built out as your team sees fit. Part 11 requires a company using an electronic tool to control records to validate that system — and we want to make that as easy as possible for you.
No software product is "validated" in a box. Validation depends on how the tool is used.
Set up your organization
Invite your team and assign them to their roles. This is the IQ part of the story — and because the app runs as one service, the installation qualification is handled by us.
Adopt our evidence as your own
We give you a leverage package: requirements, test traceability, the recorded execution of the OQ, and our own change-control process. You review it and file it as supplier evidence.
Author your procedures
Every organization gets a package of template procedures and forms. Four are essential to validating your setup — adapt them as you see fit, and by releasing them you qualify the system.
Qualify it on your own documents
Using our PQ guidance template, run your documents through the approval workflow and record the results. That gives you objective evidence the system performs for its intended use, operated by trained people under approved procedures.
Stay validated as we ship
Every release comes with a change-impact classification telling you whether anything touches your validated state — and exactly what to re-verify, if anything at all.
The regulations shaped the product, not the other way around.
Electronic signatures & records
Signature manifestations, content binding, and an audit trail that cannot be altered after the fact.
The modernized regulation
Document and record controls aligned to the quality system regulation as it stands today.
Clause-mapped controls
Templates and controls mapped to the clauses your notified body will ask about.
Request a pilot.
You're already comparing options. Compare ours — set up on your own documents, operational on day one.