21 CFR Part11

 

21CFR Part 11

21 CFR Part 11 is a set of regulations issued by the US Food and Drug Administration (FDA) in 1997, which defines the criteria under which electronic records and electronic signatures are considered equivalent to paper records and handwritten signatures. The regulation applies to all FDA-regulated industries, including pharmaceutical, medical device, biotech, and food companies.

The purpose of Part 11 is to ensure that electronic records and signatures are trustworthy, reliable, and legally binding. Part 11 establishes requirements for electronic records and signatures, including the following.

• ·         Electronic records must be secure, reliable, and accurate.
• ·         Electronic signatures must be unique and verifiable.
• ·         Electronic records and signatures must be protected from unauthorized         access, alteration, or deletion.
• ·        The system used to generate electronic records and signatures must be         validated to ensure its accuracy, reliability, and consistent performance.
• ·         Procedures must be in place to ensure the integrity and confidentiality of       electronic records.
• ·        Electronic records must be retained for the required period of time and           must be accessible for inspection and copying by authorized personnel.

The following is the table for 21 CFR Part 11 Checklist.

21CFR11 Reference	Requirement
11.10(a)	Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
11.10(b)	The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency.
11.10(c)	Protection of records to enable their accurate and ready retrieval throughout the records retention period.
11.10(d)	Limiting system access to authorized individuals.
11.10(e)	Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.
11.10(f)	Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.
11.10(g)	Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.
11.10(h)	Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.
11.10(i)	Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.
11.10(j)	The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification.
11.10(k)(1)	Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.
11.10(k)(2)	Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.
11.50(a)(1), (2) ,(3)	(1) The printed name of the signer; (2) The date and time when the signature was executed. (3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.
11.50 (b)	The items identified in paragraphs (a)(1), (a)(2) and (a)(3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout).
11.70	Electronic 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.
11.100 (a)	Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.
11.100 (b)	Before an organization establishes, assigns, certifies, or otherwise sanctions an individual`s electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual.
11.100 (c)	Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures.
11.200 (a)(1)	Electronic signatures that are not based upon biometrics shall: (1) Employ at least two distinct identification components such as an identification code and password.
11.200 (a)(2)	Electronic signatures that are not based upon biometrics shall: (2) Be used only by their genuine owners.
11.200 (a)(3)	Electronic signatures that are not based upon biometrics shall: (3) Be administered and executed to ensure that attempted use of an individual's electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals.
11.200 (b)	Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners.
11.300 (a)	Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination of identification code and password.
11.300 (b)	Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging).
11.300 (c)	Following loss management procedures to electronically DE authorize lost, stolen, missing, or otherwise potentially compromised tokens, cards, and other devices that bear or generate identification code or password information, and to issue temporary or permanent replacements using suitable, rigorous controls.
11.300(d)	Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and Report in an immediate and urgent manner any attempts at their unauthorized use to the system security unit, and, as appropriate, to organizational management.
11.300(e)	Initial and periodic 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.