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.
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.
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.