The document discusses FDA regulations on electronic records and electronic signatures (Part 11). It summarizes that Part 11 establishes criteria for electronic records and signatures to be considered equivalent to paper records. It defines controls for closed and open systems, including limiting access, operational checks, authority checks, device checks, education for system users, policies for electronic signatures, and controls over documentation and data.

1. Presented by
Karn Barot
Executive-Emcure Pharma
2016

2. 1. Title 21 of the Code of Federal Regulations that
establishes the United States Food and Drug
Administration (FDA) regulations on electronic
records and electronic signatures (ERES).
2. Part 11 as it is commonly called, defines the criteria
under which electronic records and electronic
signatures are considered trustworthy, reliable, and
equivalent to paper records.

3. 1. In March of 1997, FDA issued final part 11 regulations that
provide criteria for acceptance by FDA, under certain
circumstances, of electronic records, electronic signatures
and handwritten signatures executed to electronic records
as equivalent to paper records and handwritten signatures
executed on paper. These regulations, which apply to all
FDA program areas, were intended to permit the widest
possible use of electronic technology, compatible with FDA's
responsibility to protect the public health.

4.  Subpart A – General Provisions
• Scope
• Implementation
• Definitions
 Subpart B – Electronic Records
• Controls for closed systems
• Controls for open systems
• Signature manifestations
• Signature/record linking
 Subpart C – Electronic Signatures
• General requirements
• Electronic signatures and controls
• Controls for identification codes/passwords

5. 1. limiting system access to authorized individuals
2. Use of operational system checks
3. Use of authority checks
4. Use of device checks
5. Determination that persons who develop, maintain, or use
electronic systems have the education, training, and
experience to perform their assigned tasks
6. Establishment of and adherence to written policies that hold
individuals accountable for actions initiated under their
electronic signatures
7. Appropriate controls over systems documentation
8. Controls for open systems corresponding to controls for
closed systems bulleted above

6. 1. Access Management
2. User Management System and Privileges
3. Electronic Data
4. Audit Trial
5. Electronic Signature
6. System and Data Backup

7.  "Part 11, Electronic Records; Electronic
Signatures — Scope and Application". U.S
Food & Drug Administration. U.S Food &
Drug Administration. Retrieved 15
September 2016