What is 21 CFR Part 11?:
21 CFR Part 11:
Allow the industry to use electronic records and signatures alternatively to paper records and hand-written signatures
21 CFR Part 11 applies:
To all FDA regulated environments
When using computers in the creation, modification, archiving, retrieval or transmission of data or records
To records required by predicate rules – GLP, GCP, GMP – that impact patient safety
To new and old systems
Purpose of Part 11
Ensure data is not corrupted or lost
Data is secure
Approvals cannot be repudiated
Changes to data can be traced
Attempts to falsify records are made difficult and can be detected
Types of Systems
Two types of systems that come under 21 CFR Part 11 – closed and open systems
Closed and Open Systems:
What is a Closed system?
A system to which access is controlled by person responsible for electronic records stored on it
What is an Open system?
A system to which access is not controlled by those responsible for the electronic records stored on it
21 CFR Part 11 Requirements:
21 CFR Part 11 lists the following controls for closed systems:
Validation
Device checks
Operational system checks
Accurate and complete copies
Accurate and steady retrieval
Limited access to systems and data
Authority checks
Electronic audit trail
Training/qualification of personnel
Accountability of signatures
Control over system documentation
Digital Signatures :
Use of digital signatures for open systems
Electronic Signatures
Requirements for signed electronic records
Linking records to signatures
2. What is 21 CFR Part 11?
21 CFR Part 11:
• Allow the industry to use electronic records and signatures
alternatively to paper records and hand-written signatures
21 CFR Part 11 applies:
- To all FDA regulated environments
- When using computers in the creation, modification, archiving,
retrieval or transmission of data or records
- To records required by predicate rules – GLP, GCP, GMP – that
impact patient safety
- To new and old systems
3. Purpose of Part 11
• Ensure data is not corrupted or lost
• Data is secure
• Approvals cannot be repudiated
• Changes to data can be traced
• Attempts to falsify records are made difficult
and can be detected
Types of Systems
Two types of systems that come under 21 CFR
Part 11 – closed and open systems
4. Closed and Open Systems
What is a Closed system?
What is an Open system?
A system to which access is controlled by
person responsible for electronic records
stored on it
A system to which access is not
controlled by those responsible for the
electronic records stored on it
5. 21 CFR Part 11 Requirements
21 CFR Part 11 lists the following controls for closed systems:
- Validation
- Device checks
- Operational system checks
- Accurate and complete copies
- Accurate and steady retrieval
- Limited access to systems and data
- Authority checks
- Electronic audit trail
- Training/qualification of personnel
- Accountability of signatures
- Control over system documentation
6. Digital Signatures
• Use of digital signatures for open systems
Electronic Signatures
• Requirements for signed electronic records
• Linking records to signatures
7. Want to learn more about 21 CFR Part 11, its
requirements and best practices to comply with them?
ComplianceOnline webinars and seminars are a great
training resource. Check out the following links:
• Learning from Recent FDA Warning Letters Related to
Part 11
• Understanding and Implementing FDA'S 21 CFR Part 11
• How to Comply with 21 CFR Part 11 Requirements for
Electronic Medical Records
• Computerized System Validation - A Detailed Insight
• 21 CFR Part 11: How to Successfully Prepare for and
Host an FDA Inspection
• Complying with 21CFR Part 11-Understanding the Role
of Predicate Rules
