Q: How should documents be protected? A: Electronic records must not be damaged and must be easily accessible throughout the retention period. This is usually done through a combination of technological and procedural controls. Read more about record protection requirements It is important to note that the exercise of FDA discretion described in this guide is limited to certain Part 11 requirements (with the exception of existing systems, where the scope of enforcement discretion will be broader in certain circumstances). We intend to apply all other provisions of Part 11, including but not limited to certain closed system controls in § 11.10. For example, we intend to apply the following control provisions and requirements: we are currently reviewing Part 11 and assume that we will begin to establish rules to revise the provisions of these regulations. To avoid unnecessary expenditures on resources to meet the requirements of Part 11, we are publishing these guidelines to describe how we intend to exercise our enforcement discretion with respect to certain Part 11 requirements when revising Part 11. As noted above, Part 11 will remain in effect during this review period. The Agency intends to exercise a margin of application with respect to the specific requirements of Part 11 relating to time-stamped computer-generated audit trails (§ 11.10(e), (k)(2) and any corresponding requirements of § 11.30). Individuals must continue to comply with all applicable default rules relating to documentation, for example, of the date (e.g., § 58.130(e)), time or order of events, as well as any requirement to ensure that changes to records do not obscure previous entries.
While there are many software systems that meet 21 CFR Part 11 certification requirements, many of them have narrowly defined uses, such as product labeling, document control, or electronic batch records management. Q: What are the requirements for electronic signatures? A: All electronic signatures must: 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. Q: What are the training requirements for 21 CFR 11 compliant programs? A: Users must be documented to have the education, training and experience necessary to use the computer system. As a general rule, training can be covered by your company`s training procedures. More information on the education, training, and experience required for 21 CFR 11 In March 1997, the FDA issued final regulations for Part 11 that include criteria for FDA acceptance of electronic records, electronic signatures, and handwritten signatures made in electronic records as equivalent to paper records and handwritten signatures on paper in certain circumstances. These regulations, which apply to all FDA program areas, are expected to allow for the widest possible use of electronic technology, which is consistent with the FDA`s responsibility to protect public health. Q: What are the requirements of 21 CFR 11? A: 21 CFR 11 requires that closed computer systems have a set of technological and procedural controls to protect data inside the system.
Open IT systems must also include controls to ensure that all records are authentic, incorruptible and (where appropriate) confidential. Complies with subsections A, B and C, section 11.3 by providing audit trail, reporting, and electronic signature with timestamp capabilities. Security features include duplicate passwords for document approval. It also has password expiration, encryption, and certification. Account lockout prevents unauthorized users from accessing the system. Some general ERP systems, such as IFS, which can perform many functions related to medical device manufacturing, can also be certified to FDA CFR 21 Part 11 compliance. In this way, much of the quality system records can be automated, which would otherwise have to be duplicated outside the ERP system into a separate system, compliant with Part 11 of 21 CFR. We have a comprehensive guide to CFR Part 11 and electronic signatures with examples of how DocuSign solutions meet requirements. This document provides guidance to individuals who, pursuant to a requirement of a law or other part of FDA regulations to maintain records or submit information to the FDA3, have elected to retain the records or submit certain information electronically and, therefore, are subject to Part 11. Part 11 applies to documents in electronic form that are created, amended, retained, archived, retrieved or transmitted in accordance with the document requirements set out in the Agency`s rules. Part 11 also applies to electronic records submitted to the Agency in accordance with the Federal Food, Drugs and Cosmetics Act (Act) and the Public Health Services Act (PHS Act), even if these records are not specifically identified in the Agency`s regulations (§ 11.1).
The underlying requirements set out in the Act, PHS Act, and FDA regulations (excluding Part 11) are referred to in this guidance document as predicate rules. When FDA-regulated inspectors call, they want to see the records. Every 21 CFR Part 11 implementation should have a way to generate reports and documents that do not require a database expert to develop a custom query. Gain a competitive advantage with MasterControl™ Quality Excellence. Automate and integrate all quality processes. Respond faster to the requirements of Part 11 of 21 CFR and get to market faster. While a summary of Part 11 of the FDA`s 21 CFR is available to discuss the FDA`s interpretation of the regulations, Part 11 of the 21 CFR may still be difficult to navigate. To help you assess a system`s compliance with CFR 21 Part 11, we provide the following 21 CFR Part 11 compliance checklist.
Please note that this does not constitute legal advice of any kind. As you know, the requirements for the use of electronic signatures are set out in Part 11. 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. However, as more and more medical device manufacturers have moved from paper-grade systems to electronic quality systems, they are subject to a whole host of new regulations: FDA CFR 21 Part 11. Complies with Subsection B, Section 11.10 by automating the management of all training processes. Easily route, track and intensify training. Provide online exams, enable group approval, and automate sequencing of training tasks. The term “Part 11” refers to documents in electronic form that are created, modified, retained, archived, retrieved, transferred, or submitted in accordance with the requirements of FDA regulations/predicate rules.