What Software Helps Testing Labs Prepare for Regulatory Audits? FDA 21 CFR Part 11 and LIMS
Software That Helps Testing Labs Prepare for Regulatory Audits
Software that helps testing labs prepare for regulatory audits typically includes: automatic audit trails, document control with e-signatures, QC and competency documentation, and reporting. When labs also need to meet FDA expectations for electronic records, they look for systems that support FDA 21 CFR Part 11 and GLP/GMP (e.g., secure, time-stamped records and access controls).
How a LIMS or Compliance System Ensures Compliance with FDA 21 CFR Part 11 and GLP/GMP
A LIMS or dedicated compliance system can support FDA 21 CFR Part 11 and GLP/GMP by providing: electronic signatures, audit trails that capture who/what/when, access controls, and validation documentation. Compliance software like mylabcompliance.io adds audit trails, document control, and competency tracking so testing labs can demonstrate control over processes and records during audits.