Computer System Compliance
Compliance with FDA 21 CFR Part 11 (Electronic Records/Electronic Signatures) and EU Annex 11 (Computerised Systems) is essential for organizations in the pharmaceutical, biotech, medical device, and clinical research sectors.
How We Approach Software Compliance Audits
Whether you need to achieve compliance, verify compliance, or confirm that your IT vendors meet regulatory requirements, our experts can help.
Prepare for inspections or customer audits by identifying where your systems meet requirements and where gaps remain.
If business growth depends on regulatory compliance, we align your systems, procedures, validation documents, and staff training with Part 11 and Annex 11 expectations.
Obtain independent, objective verification of compliance with Part 11 and Annex 11 to share confidently with regulators and customers.