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OpenLAB ELN Supporting 21 CFR Part 11 Compliance

Part 11 in Title 21 of the Code of Federal Regulations includes the US Federal guidelines for storing and protecting electronic records and applying electronic signatures. The intent of these guidelines is to ensure that electronic records subject to these guidelines are reliable, authentic and maintained with high integrity.

This document examines each section of 21 CFR Part 11 and provides a recommended remediation approach using Agilent OpenLAB ELN v4.0.

OpenLAB ELN manages experiments and documents that are very similar to paper notebooks (i.e. a set of pages). The “Electronic Records” managed by OpenLAB ELN are herein termed “OpenLAB ELN documents”. According to recent guidance from FDA “Guidance for Industry, Part 11, Electronic Records; Electronic Signatures – Scope and application”, part 11 would apply when persons choose to use records in electronic format in place of paper format.