21 CFR part 11-�ELECTRONIC RECORDS;�ELECTRONIC SIGNATURES

21 CFR part 11-�ELECTRONIC RECORDS;�ELECTRONIC SIGNATURES

1. 21 CFR part 11- ELECTRONIC RECORDS; ELECTRONIC SIGNATURES Presented By: Hitesh S. Sonawane Course:1 st Yr M. Pharm (Regulatory Affairs) Presented To: Dr. Pankaj P. Nerkar (HOD Regulatory Affairs)

2. INTRODUCTION 2

3. Organizations operating in US Can use Electronic quality & Digital records Signatures Paper based documentation & wet signatures FDA regulations In such way that complies with 21 CFR Part 11 Describes how 3

4. Title > Chapter > Sub chapter > Part > Subpart Electronic Electronic Signatures & records The CFR is Organized as 21 CFR Part 11 establishes US FDA regulations Defines criteria under which on Trustworthy, Reliable Equivalent to paper records 4

5. CFR 21 PART 11 ELECTRONIC RECORDS ELECTRONIC SIGNATURES 5

6. 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 signature components &controls -Controls for identification codes/ passwords 21 CFR PART 11 3 sub parts Divided into Code of Federal Regulations Specific to electronic records & electronic signatures, which includes electronic submissions to the FDA Coded (numbers & letters) set of laws published by the federal government of the US Which is Section of the CFR that applies to food & drugs Title 21 Which is 6

7. SUBPART A:GENERAL PROVISIONS 11.1 Scope: Electronic records to be trustfully, reliable, & generally equivalent to paper records. Records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted. Electronic signatures to be equivalent to handwritten signatures, & other general signing. Electronic records may be used in place of paper records. 11.2-Implentation : For records required to be maintained but not submitted to the agency provided that the requirements of this part are met . For record submitted to agency 1. The requirement of this part are met 2. Documents to be submitted have been identified in public 7

8. 11.3-Definition: 1. Biometrics - means a method of verifying an individual's identity based on physical features & actions are both unique to that individual. 2. Electronic Records - means any combination of text, graphics, data, pictorial in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. 3. Electronic signature - means a computer data compilation of any symbol or series of symbols executed, adopted or authorized by an individual to be legally binding equivalent of the individuals handwritten signature 8

9. SUBPART B-ELECTRONIC RECORDS Discusses Signature manifestations Closed system Requirements for administration of closed &open electronic record Keeping systems Controls to ensure that all records are authentic, incorruptible & confidential Open system that transmit data via Internet Must have Collection of technological & procedural controls to protect data within system Must have Build that only testers or developers responsible can access Requirements for establishing a link between signature & records 9

10. using Organizations Must establish & document Controls for closed system Authenticity, integrity & confidentiality of data Validation Human readable records Protection of records Limiting system access Audit trails Authority checks Determination of persons & education System documents Document encryption Digital signature Controls for open system Electronic records That ensures Additional measures Procedures & controls 10

11. Each of these must be readable by display or printout Printed name of signer Date & time of signature Purpose of the signature (Ex: review, approval etc ) Signature/record linking Signature Manifestations Must include Electronic signature & handwritten signatures must be linked to their respective electronic records Signatures cannot be excised, copied, transferred or falsified To ensure 11

12. FDA SUBPART C - ELECTRONIC SIGNATURES Person who will be using an electronic signature must: Have their identity confirmed & Use a unique signature that has never been & will never be used by another individual Must inform in advance to Electronic signatures Controls for identification codes/passwords Electronic signature components & controls General requirements Organizations Planning to use Include 12

13. The certification shall be submitted in paper form & signed with a traditional handwritten signature, to the office of Regional Operations Persons using electronic signatures shall, upon agency request, provide additional certification that a specific electronic signature is the legally binding equivalent of the signers handwritten signature. Before an organization establishes, assigns, certifies, or otherwise individuals' electronic signature or any element of such electronic signature, the organization shall verify the identity of the individual. Each electronic signature shall be unique to one individual & shall not be reused by or reassigned to anyone else VERIFY THE IDENTITY CERTIFY TO THE AGENCY UNIQUE General Requirements: 13

14. Be used only by their genuine owners Be administered and executed to ensure that attempted use of an individual's electronic signature by anyone other than is genuine owner, requires collaboration of two or more individuals. Electronic signature components: Biometric Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners. Non-Biometric 14

15. Controls for identification codes/password: Persons who use electronic signatures based upon use of identification codes in combination with passwords shall employ controls to ensure their security and integrity. Such controls shall include: Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination of identification code and password. Ensuring that identification code and password issuances are periodically checked, recalled, or revised. Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes Uniqueness Codes & Password Periodically Checked 15

16. REFERENCES:- 1. https://www.ecfr.gov/current/title-21/chapter-l/subchapter-A/part-11 2. https://www.slideshare.net/AshishChaudhari27/cfr-21-part-11 16

17. 17