The FDA’s 21 CFR Part 11 regulation outlines requirements for electronic records and signatures for medical device companies. Part 11 compliance is complex, going far beyond just having validated systems and audit trails. Many companies believe they are compliant when in reality they are not fully meeting the FDA’s expectations.
What Does 21 CFR Part 11 Cover?
Part 11 covers the administration of electronic documentation within a quality management system. This includes:
- Proper use of computer systems and responses to system issues
- Secure data storage and integrity
- Electronic signature traceability
- Change control and falsified record prevention
Who Needs to Comply With 21 CFR Part 11?
If a medical device company uses any electronic systems for storing, accessing, or modifying regulated data, they need to comply with Part 11. This includes:
- Electronic data storage systems
- Online file sharing platforms
- Scanned paper record repositories
- Quality management software
Even companies that call their paper records the “master” files need to comply if they digitize or upload any of those documents electronically.
Per section 11.1, if a company employs computer systems for activities like design controls, purchasing, device history records, production, quality assurance, labeling, distribution, complaint handling, and CAPA, they likely fall under Part 11 rules.
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Part 11 Compliance Checklist for Medical Device Companies
6 Steps to Achieve FDA 21 CFR Part 11 Compliance
Achieving full compliance takes considerable effort. Here are six key steps medical device companies should take:
1. Limit System Access and Require Secure Passwords
Part 11 requires controlling access to regulated systems and data. Specifically:
- Carefully control user permissions and access
- Have unique usernames and passwords (no generic logins)
- Follow password best practices:
- Minimum 8 characters
- Mix of letters, numbers and symbols
- Require periodic changes
- Lock accounts after failed logins
Access should be limited to only appropriate personnel. For example, developers and IT staff would not need access to quality system records unless job duties dictate otherwise.
2. Maintain Detailed Audit Trails
Thorough audit trails that track all system and data activity must be maintained. These include exact details like:
- Username
- Timestamp reflecting time and date
- Actions taken on data
- Before and after data states for modifications
Audit reports need to be readily reproducible and available for regulators to review during inspections. Reports should also be proactively reviewed internally on a periodic basis to identify any data integrity issues.
3. Follow E-Signature and Documentation Requirements
Part 11 defines specific requirements for electronic signatures and documentation. These include:
- Accurate time/date stamps for any documentation changes
- Full traceability of signing authorities
- Safeguards restricting ability to backdate records
- Requiring two independent signatures for critical data modifications
Companies also need to inform the FDA in writing if plans to use electronic signatures across regulated records and systems.
4. Validate Systems to Meet Part 11
Validation activities are required to ensure systems consistently meet Part 11 requirements. These assessments include:
Installation Qualification: Ensures correct system installation, configuration and operational readiness
Operational Qualification: Tests the actual functionality of the system and its ability to meet all Part 11 technical requirements
Performance Qualification: Verifies system operation under normal production conditions
It’s vital companies do not solely rely on vendors for validation. They must take accountability to execute protocols themselves.
5. Don’t Outsource Compliance Responsibilities
While software vendors can provide compliant tools, documentation, and guidance, the regulatory responsibility lays with the medical device company, not vendors. Before buying any solutions that will store or manage regulated data, companies must fully understand their responsibilities.
6. Select a Compliant QMS Solution
A quality management system designed specifically to meet Part 11 can simplify compliance efforts. Key software capabilities that enable compliance include:
- Configurable user permissions to appropriately limit system access
- Workflows with electronic signatures bound to individual users
- Automated activity logging for detailed audit history reporting
- Easy access to audit trails for internal review or regulatory inquiry
Also verify software is pre-validated and designed expressly for medical device quality systems.
Assessing Part 11 Compliance with Greenlight Guru
Greenlight Guru provides medical device companies with cloud-based QMS software designed expressly for 21 CFR Part 11 compliance. A few key features that support compliance include:
Secure cloud hosting – Validated infrastructure and security protocols to protect data integrity
Permission-driven access – Pre-defined user roles to appropriately limit system access
Automated activity logging – Detailed audit trail reports for any system or data changes
Electronic signature controls – Bind unique users to records with integrated approval workflows
Turnkey validation packages – Installation and operational qualification documentation to simplify validation
Schedule a demo to learn more about how Greenlight enables sustained Part 11 compliance throughout the product lifecycle – from design controls to CAPAs.
Frequently Asked Questions About 21 CFR Part 11 Compliance
Here are answers to some common questions medical device companies have about Part 11 compliance:
1. Do I still need to comply with Part 11 if my main quality system is paper-based?
Yes, Part 11 rules apply for all electronic systems that store or process regulated data related to device design, production, or quality processes. Even if you maintain paper as the primary records, scanned documents, secure folders, online collaboration tools or other electronic systems still need to meet compliance.
2 .What happens if the FDA finds my company non-compliant with 21 CFR Part 11 during an inspection?
If regulators determine your company does not meet requirements, they will issue formal citations called Form 483 observations or warning letters depending on severity. This can delay product approvals and potentially trigger recalls or other sanctions if corrective actions are not satisfactory and timely.
3. What electronic signatures approaches meet 21 CFR Part 11 requirements?
Electronic signatures based on unique usernames and passwords are generally accepted, though should have controls in place to ensure traceability. More advanced options like biometrics or public key infrastructure (PKI) cryptography also comply but have higher complexities. One generic system login shared by multiple people would not meet requirements.
Conclusion
Achieving FDA 21 CFR Part 11 compliance requires extensive effort but is critical for medical device companies to avoid regulatory scrutiny.
Common pitfalls to avoid:
- Assuming paper master records negate Part 11 requirements
- Not limiting system access or managing passwords effectively
- Lacking detailed audit trails
- Using same signatures across records
Companies that put the right QMS and security controls in place and validate their systems appropriately can feel confident in sustaining compliance with this vital regulation.