21 CFR PART 11 Scope and Application Electronic Records; Electronic Signatures

21 CFR PART 11 Scope and Application Electronic Records; Electronic Signatures.

Code of Federal Regulations. The code of federal regulations ( CFR ) is the codification of the general and permanent regulations published in the federal register by the executive departments and agencies of the federal government of the united states . Title 21 of the CFR is reserved for rules of the food and drug administration. Each title (or volume) of the CFR is revised once each calendar year. A revised title 21 is issued on approximately April 1 st of each year. In addition to this annual edition, the CFR is published in an unofficial format online on the Electronic CFR website, which is updated daily Each title is divided into chapters, subchapters, parts, and sections. Title 21 concerns the area of food and drug, chapter 1 is related to FDA, part 11is the sub-section of this chapter it focuses on E lectronic records; electronic signatures..

Content of 21 CRF part 11. 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.

Electronic records to be trustful, reliable, and generally equivalent to paper records. Records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. Electronic signatures to be equivalent to handwritten signatures, and other general signings. Electronic records may be used in place of paper records computer systems (including hardware and software) controls, and attendant documentation maintained under this part shall be readily available and subject to, fda inspection..

For records submitted to the agency, or for records required to be maintained but not submitted to the agency, persons may use electronic records in place of paper records or electronic signatures in place of traditional signatures, in whole or in part, provided that: 1. The requirements of this part are met; and 2. The document or parts of a document to be submitted have been identified in public docket no. 92s-0251..

Electronic record : any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. Electronic signature : a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. Biometrics means a method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable. Digital signature means an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified. Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instruments such as a pen or stylus is preserved.

11.10-controls for the closed system- A closed system is controlled by the 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 authentically, integrity, and, when appropriate, the confidentially of electronic records. E.g., the owner of the system. 11.30-controls for the open system- Open system to which it is not controlled by those responsible for the electronic records stored on it . People responsible for data content also control the system. Thus, due to issues of confidentiality, authenticity , and data integrity threat as it can be accessible by all..

11.50 signature manifestations Signed electronic records shall contain the following: (1) the printed name of the signer; (2) the date and time when the signature was executed; and (3) the meaning (such as review, approval, responsibility, or authorship) associated with the signature. 11.70 Signature/record linking: E lectronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means..

Unique Verify the identity Certify. Subpart-c : electronic signatures.

1. UNIQUE. Each electronic signature shall be unique to one individual and shall not be reused by , or reassigned to, anyone else..

2. VERIFY THE IDENTITY. Before an organization 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..

The certification shall 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.

1. Nonbiometric: electronic signatures that are not based Upon biometric shall: employ at least two distinct Identification components such as an identification code And password. 2. Biometric: electronic signatures based upon Biometric shall be designed to ensure that they Cannot be used by anyone other than their genuine Owners..

Uniqueness Code Password Periodically Checked Periodic testing of devices.

CONTROL FOR IDENTIFICATION OF PASSWORD/CODES. UNIQUENESS OF CODE.

A Walk-Through of FDA 21 CFR Part 11 – Tismo – The Design & Engineering Firm.

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