Enterprise Paperless Validation
You’ve decided validation should run paperless across the estate. This is the backbone for that move: the platform and electronic-records system that digital validation runs on at enterprise scale, with the lifecycle doing the thinking and every site staying audit-ready.
Paper-based
Binders, wet signatures, scattered evidence, ~6M records a year.
Paperless platform
Electronic records and signatures, workflow and RPA automation, audit-ready and traceable on demand. 21 CFR Part 11 / Annex 11.
What it is
A validated, paperless platform that holds the whole validation record electronically: specifications, risk assessments, test evidence, electronic signatures, and the audit trail, all under 21 CFR Part 11 and Annex 11. Workflow and RPA automation remove the manual handling, and evidence is traceable and producible on demand rather than reconstructed before an inspection.
What changes
Across a comparable programme of 40-plus sites, going paperless removed around six million paper records a year and cut validation cycle times by roughly 45%, while compliance cost fell and inspection readiness improved. It is the backbone the digital validation lifecycle and Modular Qualification both depend on.
Key takeaways
- Paper is not just slow; it is where evidence goes missing before an inspection.
- One electronic backbone makes validation traceable and producible on demand.
- It is the system of record that digital validation and modular qualification run on.