Home Services CMC & Quality Compliance21 CFR Part 11 Compliance

21 CFR Part 11 Compliance

Digital Integrity in a Regulated World

Overview

As pharma goes digital, compliance with 21 CFR Part 11 (and EU Annex 11) is non-negotiable. We help you validate your electronic systems to ensure data integrity, security, and traceability. From eQMS to LIMS, we ensure your digital footprint meets the highest regulatory standards.

Key Features

System validation (IQ/OQ/PQ)

Electronic signature implementation

Audit trail review and remediation

User access control policies

Our Process

Inventory & Assessment

Cataloging your systems and determining Part 11 applicability.

Validation Execution

Testing systems to prove they perform as intended and secure data.

SOP Development

Writing the procedures that govern system use and maintenance.

Project Complete & Deliverables Provided

Frequently Asked Questions

Any electronic system used to create, modify, maintain, or transmit records required by other FDA regulations. This includes LIMS, ERP systems, electronic batch records, analytical instruments with data output, and stability chambers. If it touches GMP data, it likely needs Part 11 controls.