In section 11.1 Scope (a), the Regulations set out the criteria for electronic records and electronic signatures that they are considered trustworthy, reliable and equivalent to paper records and handwritten signatures. Simply put, the regulation describes the processing of electronic documents that are part of electronic quality management systems (eQMS) and other quality-critical applications. Actions related to the operation of hardware, software, and physical records involved in your company`s quality management system should be well documented. (d) Electronic records that meet the requirements of this Part may be used in place of paper records in accordance with § 11.2, unless paper records are expressly required. Part 11 of Title 21 of the Code of Federal Regulations, or 21 CFR Part 11, more commonly referred to as “Part 11”, is a set of rules that set out the requirements for electronic records and signatures. While the FDA 21 CFR Part 11 regulatory framework may be difficult to meet initially, all requirements have been designed to meet the changing needs of life sciences companies. In addition, the Part 11 Regulations may contribute to: (b) This Part applies to records in electronic form created, amended, retained, archived, retrieved or transmitted in accordance with the document requirements set out in the Agency`s rules. This Part also applies to electronic records submitted to the Agency in accordance with the requirements of the Canada Food, Drugs and Cosmetic Act and the Public Health Services Act, even if such records are not specifically listed in the Agency`s regulations. However, this Part does not apply to paper documents that are or have been transmitted electronically.
Therefore, QMS software that complies with Part 11 of 21 CFR should be able to monitor and control quality procedures through the phase gate process. Such a workflow ensures that records are created, reviewed as needed, and approved by specific employees. (g) This Part does not apply to electronic signatures obtained in accordance with paragraph 101.11(d) of this Chapter. e) Computer systems (including hardware and software), controls, and accompanying documentation managed in accordance with this Part shall be readily available for and subject to FDA inspection. (a) The rules set out in this Part set out the criteria according to which the Agency considers electronic records, electronic signatures and handwritten signatures executed in electronic records to be trustworthy, reliable and generally equivalent to paper records and handwritten signatures on paper. b) The following definitions also apply to this part: This means that regular validation checks of the system software must be carried out. This ensures that all elements of your system work as expected. In addition, you must record the results of the validation tests. These are the key requirements for a compliant eQMS described by the FDA that you should consider when implementing a document management solution. The life sciences industry is known for a variety of regulations and guidelines that companies must comply with.
To date, however, some companies are struggling to fully meet the requirements of Part 11 of 21 CFR. Life sciences companies will certainly benefit from full compliance with the requirements of Part 11 of 21 CFR described in this article. Not only because it helps get your product to market faster, but also serves as a catalyst for the protection of confidential information. (b) the elements referred to in points (a)(2) and (a)(3) of paragraph 1 of this Section shall be subject to the same checks as electronic records and shall be included in any form of human-readable electronic record (e.g. electronic display or printing). (a) The definitions and interpretations of terms contained in section 201 of the Act apply to those terms when used in this Part. “(b) Part 11 of 21 CFR applies to documents in electronic form that are created, amended, retained, archived, retrieved, or transmitted in accordance with the document requirements established by the FDA.” (c) If the electronic signatures and related electronic records meet the requirements of this Part, the Agency considers the electronic signatures to be equivalent to complete handwritten signatures, initials and other general signatures. Signatures in accordance with the agency`s rules, unless expressly provided for in the rules entering into force on or after 20 August 1997. Read more about QMS Software Validation – When is it necessary? (2) Review and change control procedures to maintain an audit trail that documents the development and modification of system documentation over time. (3) Be managed and executed in such a way as to ensure that the attempt to use a person`s electronic signature by a person other than its beneficial owner requires the cooperation of two or more persons. (7) Electronic signature: a compilation of computer data of a symbol or series of symbols executed, adopted or approved by a person in order to be the legally binding equivalent of the person`s handwritten signature. Electronic signatures and handwritten signatures executed in electronic records are linked to their respective electronic records to ensure that signatures cannot be cut, copied or otherwise transmitted to falsify an electronic record in the usual manner.
(6) Electronic recording is any combination of text, graphics, data, audio, images or other representations of information in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system. (a) Each electronic signature is unique to one person and may not be reused or transmitted to third parties by another person. As explained in the article above, Part 11 of 21 CFR is a set of rules that set out what is required for electronic records and signatures to be equivalent to paper records and handwritten signatures. In particular, the regulation describes records management in electronic quality management systems (eQMS) for life sciences and other FDA-regulated industries. (b) the ability to make accurate and complete copies of records, both legible and electronic, that can be inspected, verified and reproduced by the Agency. Individuals should contact the Agency if there are any questions about the Agency`s ability to conduct such verification and reproduction of electronic records. Therefore, any creation, modification, or deletion of a record should be automatically saved to an audit history file. Also, the file must not be editable. This audit trail documentation must be retained for a period of time and is available to FDA reviewers for review and copy if necessary.
1. Adequate controls over the distribution, access and use of documents for the operation and maintenance of the system. `(b) the ability to make accurate and complete copies of records, both legible and electronic, which can be inspected, verified and reproduced by the Agency …`. This means that not only do your documents fall within the scope of application, but also: (i) determine that people who develop, maintain or use electronic records/electronic signature systems have the education, training and experience necessary to perform the tasks assigned to them. In Section 11.10 Controls for Closed Systems, the FDA requires: The main difference is how Schedules 11 and 11 address risk management. Annex 11 lists risk assessment as a starting point for compliance activities. Part 11 does not contain any indication of risk or criticality, but focuses on the security of open and closed systems. (b) Before an organization establishes, assigns, certifies or otherwise sanctions a person`s electronic signature or any element of that electronic signature, the organization shall verify the identity of the person. Here`s what we`re going to discuss in this article: This means that the SMQe must be able to generate or export accurate and complete copies of the records stored in the system. The QMS must also be able to provide both electronic copies (export capabilities) and paper copies or printouts.
(c) persons who use electronic signatures certify to the Agency before or at the time of such use that the electronic signatures in their system used from 20 August 1997 onwards are the legally binding equivalent of traditional handwritten signatures. f) Use of operating system checks to apply the permissible sequence of steps and events, as appropriate. (8) Handwritten signature means the written name or legal mark of a person that was handwritten by that person and signed or accepted with the present intention of certifying a writing in permanent form. The act of signing with a writing or marking instrument such as a pen or pen is preserved. The written name or legal mark, although traditionally applied on paper, can also be applied to other devices that capture the name or brand. In addition, in Section 11.3 Definitions, the FDA defines “electronic registration” as follows: (5) Digital signature refers to an electronic signature based on cryptographic methods of copyright authentication and calculated using a set of rules and a set of parameters so that the identity of the signer and the integrity of the data can be verified.