Validating Electronic Records and Signatures in Pharma Systems Validating Electronic Records and Signatures in Pharma Systems Electronic Records (ER) and Electronic Signatures (ES) play a central role in modern pharmaceutical quality systems. From batch releases and lab results to training logs and deviation approvals, ER/ES are integral to digital transformation in regulated environments. But these systems must comply with 21 CFR Part 11 — a U.S. FDA regulation that outlines criteria for ensuring the trustworthiness, authenticity, and reliability of electronic records and electronic signatures. This comprehensive guide walks you through the practical steps required to validate ER/ES functionality in computerized…