An electronic Quality Management System (eQMS) must support compliance with FDA regulations. This is especially critical in highly regulated industries like pharmaceuticals, medical devices, and biotechnology. Understanding the key requirements helps ensure your eQMS is audit-ready and aligned with FDA expectations for quality and compliance.
Here are the core components your eQMS should include:
1. 21 CFR Part 11 Compliance
21 CFR Part 11 outlines requirements for electronic records and signatures. To meet these standards, an FDA-compliant eQMS must:
- Ensure secure, computer-generated, time-stamped audit trails
- Support electronic signatures with unique user authentication
- Restrict system access through role-based permissions
- Maintain data integrity and trustworthiness of records
2. Data Integrity and Audit Trails
Data integrity is essential. Your eQMS should:
- Automatically record user actions and data changes
- Capture a complete, tamper-evident audit trail
- Track the full lifecycle of each record
- Provide on-demand access to auditors and reviewers
3. System Validation
The FDA expects validation of any system used in GxP processes. Validation must be risk-based and documented, following recognized best practices:
- IQ – Verifies correct installation
- OQ – Confirms the system performs as intended
- PQ – Demonstrates performance under real-world use
4. Document Control
Document control is a core FDA expectation. Your eQMS should support:
- Controlled review, approval, and distribution
- Full version history and traceability
- Secure, centralized access to current procedures and records
5. Training Management
Employees must be trained and qualified to perform their roles. A compliant eQMS tracks:
- Training status and completion
- Role-based training assignments
- Retraining requirements and history
- Documentation of compliance during audits
6. CAPA Management
Corrective and Preventive Action (CAPA) is one of the most scrutinized areas during FDA inspections. Your eQMS should allow teams to:
- Identify, document, and investigate issues
- Perform structured root cause analysis
- Implement and track corrective actions
- Measure effectiveness over time
7. Change Control
Regulated organizations must manage change in a controlled way. Your eQMS should:
- Document proposed changes with justification
- Route changes through defined approval workflows
- Assess risks and impact
- Maintain visibility and traceability throughout the process
8. Risk Management
Risk-based thinking is now central to both FDA and ISO expectations. An FDA-aligned eQMS will:
- Support risk assessments and scoring
- Connect risk to quality processes like CAPA and change control
- Help teams prioritize based on severity and likelihood
- Align with ISO 14971 and ICH Q9 risk principles
9. Audit and Inspection Readiness
Audit management is critical to maintaining compliance. Your eQMS should:
- Centralize audit planning and scheduling
- Track findings and responses
- Provide structured reports and traceable records
- Make documentation easy to retrieve during FDA inspections
10. Supplier Quality Management
The FDA requires oversight of suppliers and outsourced processes. Your eQMS should help you:
- Qualify and approve suppliers
- Monitor supplier performance
- Manage audits, questionnaires, and risk assessments
- Maintain full traceability across the supply chain
Why This Matters
An FDA-compliant eQMS is not just about passing audits. It is about building a quality system that works with you, not against you. One that supports operational excellence while standing up to regulatory pressure. It protects your data, accelerates your processes, and ensures your team can focus on making smart, informed decisions.
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