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Cfr 21 part 11
This document provides an overview of 21 CFR Part 11, which establishes criteria for electronic records and electronic signatures. It discusses how Part 11 falls under Title 21 of the Code of Federal Regulations, which regulates the food and drug industry. The document then examines the key aspects of Part 11, including its scope, definitions of electronic records and signatures, requirements for controls on closed and open systems, requirements for electronic signature components and security, and general record keeping requirements. It provides examples of how these regulations are implemented in pharmaceutical organizations and clinical trials.
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Cfr 21 part 11
- 1. Uploadedby : Ashish RajendraChaudhari M.pharm 1st Sem 18-10-2019 1
- 2. CONTENTS • Introduction • Importance •Part11-electronic records • SubpartA:General Provisions • SubpartB:Electronic Records • SubpartC:Electronic Signatures • Conclusion • References CONTENTS • Introduction • Importance • Part11-electronic records & signatures • SubpartA:General Provisions • SubpartB:Electronic Records • SubpartC:Electronic Signatures • Conclusion • References 218-10-2019
- 3. Code ofFederal Regulation is the codification of the general and permanent rules and regulations published in the Federal Register by the executive department and agencies of the federal government of the United States. The CFR is divided into 50 titles which represent broad areas subject to federal regulation. Each title is divided into chapters, subchapters, parts, and section. Title 21 concern the area of Food and Drug, Chapter 1 is related to FDA, Part 11is the sub-section of this chapter it focuses on a specific area ( i.e., Electronic Record;Electronic Signature). 318-10-2019
- 4. 21 CFRPart 11 is an important section of the Code of Federal Regulations 21 CFR Part 11 deals with rules for electronic records and electronic signatures as set out by the FDA It need to be understood that each title and part of the CFR denotes a certain industry or activity 21 CFR is the FDA title for PHARMA and medical devices, while Part 11 relates to a specific activity, namely electronic signatures and record In 1999, computerized system that are used in clinical trials came under 21 CFR Part 11 418-10-2019
- 5. CFR 21 Part11 ELECTRONIC SIGNATURES ELECTRONIC RECORDS 518-10-2019
- 6. • 11.1-Scope • 11.2-Implementation •11.3-Defination Subpart A- General Provisions • 11.10-Control for closed system • 11.30-Control for open system • 11.70-Signature/record linking Subpart B- Electronic Records • 11.100-General requirement • 11.200-Electronic signature components • 11.300- Identification codes/passwords Subpart C- Electronic Signatures 618-10-2019
- 7. 11.1 Scope- Electronicrecords to be trustfully, reliable, and 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, and other general signing Electronic records may be use in place of paper records Computer systems (including hardware and software) 718-10-2019
- 8. A. For recordsrequired to be maintained but not submitted to the agency…..provided that the requirements of this part are met. B. For record submitted to agency 1. the requirements of this part are met 2. documents to be submitted have been identified in public 818-10-2019
- 9. Electronic record– combination oftext, graphics,data,audio, pictorial, or other information represent digital form it is modified Electronic signature- computer data of any symbol executed by an individual to be the individual written signature Digitalsignature- electronic signature base on cryptographic method Handwritten signature-the act of signing with a writing or marking instrument such as pen is preserved Biometrics-verifying individual identity base on individualphysicalfeature or action are both unique to that individual 918-10-2019
- 10. 11.10-Controls for closed system- A closed system is controlled by person responsible for electronic records stored on it Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to the authentically, integrity, and, when appropriate , the confidentially of electronic records. 1018-10-2019
- 11. A opensystem to which a is not controlled by those responsible for the electronic records stored on it People responsible for data content also control system 1118-10-2019
- 12. Electronic signaturesand handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures can not be excised, copied or otherwise transferred to falsify and electronic record by ordinary means. 1218-10-2019
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- 14. Each electronicsignature shall be unique to one individual and shall not be reused by ,or reassigned to, anyone else. 1418-10-2019
- 15. Before anorganization establishes, assigns, certifies, or otherwise individual’s electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual. At the time of joining that activity done by HR Department. For vendor in service agreement need to be clarification. 1518-10-2019
- 16. The certificationshall be submitted in paper form and 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 signer’s handwritten signature 1618-10-2019
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- 18. Electronic signaturethat are not based upon biometric shall: Employ at least two distinct identification components such as an identification code and password When an individual executes a series of signing during a single , continuous period of controlled system access, the first signing shall be executed using at least one electronic signature that used only by ,the individual. Be used only by their genuine owners; and Be administered and executed to ensure that used of an individual’s electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals 1818-10-2019
- 19. Electronic signaturebased upon biometric shall be designed to ensure that they cannot be used by anyone other than their genuine owners 1918-10-2019
- 20. Persons whouse electronic signatures based upon use of identification code in combination with passwords shall employ control to ensure their security and integrity. Such controls shall include: Uniqueness Code and password Periodically Checked Periodic testing of devices 2018-10-2019
- 21. Maintaining theuniqueness of each combined identification code and password , such that no two individuals have the same combination of identification code and password. 2118-10-2019
- 22. Ensuring thatidentification code and password issuances are periodically checked ,recalled ,or revise (e.g., to cover such events as password aging) 2218-10-2019
- 23. Initial andperiodic testing of devices, such as tokens or cards, that bear or generate identification code or password information to ensure that they function properly and have not been altered in an unauthorized manner. 2318-10-2019
- 24. Remember 21CFR Part 11 is both technical and procedural Always develop clear rationale as to how you are meeting all of the requirement Remember ,you are always responsible as end user so make sure you do proper due diligence Clearly identify what you consider to be electronic records Make sure everyone in the organization understand electronic records and electronic signatures Perform regular follow up assessment to evaluate ongoing compliance 2418-10-2019
- 25. https://en.wikipedia.org/wiki/Title 21of the Code of Federal Regulations CFR- Code of Federal Regulations Title 21.Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfcfr/c frsearch.cfm CFR-2018-TITLE21-VOL1-PART11 2518-10-2019
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