Building software that handles FDA-regulated records? Folksoft gets your systems Part 11-ready — validation, audit trails, electronic signatures, and access controls — so your life-sciences customers can trust your platform.
From the moment you connect your stack to the day a customer auditor or FDA investigator asks for evidence, Folksoft runs the program for you.
We run computer system validation aligned to FDA's Computer Software Assurance approach — and keep the evidence.
We confirm your system captures secure, computer-generated, time-stamped audit trails of record changes — tamper-evident, with the original entry never obscured.
We get your e-signature controls — signer identity, the printed name, date and time, and the meaning of the signing — Part 11-compliant and bound to the record.
Role-based access, record retention, and copy and retrieval controls implemented and documented — enforced in the identity and cloud systems you already run.
SOPs and validation documentation drafted and kept current, and evidence collected continuously — so inspection readiness is a state you stay in, not a project you restart.
Part 11 sorts every system into one of two kinds, and the answer decides which controls you have to implement.
In a closed system, access is controlled by the people who are responsible for the content of the electronic records — for example, your own internal, authenticated application. Most SaaS platforms fall here.
In an open system, access is not controlled by the people responsible for the content of the records — so Part 11 asks for additional measures, such as document encryption and appropriate digital signature standards, to keep records authentic and confidential end to end.
In short: whether your platform is a closed or open system changes which Part 11 controls apply. Folksoft classifies your system and implements the right ones.
If any of these sound like you, Part 11 is likely on your critical path.
Pharma, biotech, medical device, clinical and lab software whose systems store FDA-regulated records.
Vendors whose customers are FDA-regulated and require Part 11-compliant systems.
Startups handling GxP electronic records or applying electronic signatures to them.
Companies preparing for FDA inspections or customer audits of their software.
Everything life-sciences founders ask us before starting Part 11 readiness.
Still have questions?If your system creates, modifies, maintains, archives, retrieves, or transmits electronic records required by FDA regulations — or applies electronic signatures to them — then yes. Folksoft confirms your scope.
Part 11 is the regulation; validation is how you demonstrate your system meets it. Folksoft handles both, using FDA's newer Computer Software Assurance (CSA) approach to keep it lean.
It depends on your system's complexity and the scope of the records it holds — so there's no one-size-fits-all number. Contact us and we'll give you a tailored quote for your situation.
Yes. That's exactly what Folksoft is built for. Folksoft runs the program and pairs you with a real GRC analyst who guides you through validation, audit trails and e-signature controls — so you don't need an in-house QA or validation team.
Book a demo and we'll map your fastest path to Part 11 readiness — validation, audit trails, and electronic signatures handled.