The best document control features meet fda requirements for electronic records and signatures, but they shouldn`t match the invoice in a way that “feels” compliant or makes your company`s workflow more complex. Add them to your 21 CFR Part 11 software requirements list: These documents describe the specific requirements of a system. Typical elements covered in a document with functional requirements are: user roles, user access, process workflow, and Part 11 of 21 CFR requirements (audit trail, electronic signature). Sample Template Part 11 specifies that electronic signatures applied to documents must include the printed name of the signer, the date and time the signature was applied, and the “meaning” or intent of the electronic signature as part of an evolving, non-editable audit trail. But the demands don`t stop there. The Agency intends to exercise its enforcement discretion with respect to all Part 11 requirements for systems that were otherwise in service prior to August 20, 1997, the effective date of Part 11, in the circumstances set out below. 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. We suggest that your decision to validate computerized systems and the scope of validation take into account the impact of the systems on your ability to meet the requirements of the predicate rule. You should also consider the impact these systems may have on the accuracy, reliability, integrity, availability, and authenticity of the required records and signatures. Even if there is no predicate rule to validate a system, in some cases it may still be important to validate the system. Organizations are responsible for compliance with Part 11, including procedural or administrative controls such as software. Based on this narrow interpretation, the FDA considers that Part 11 applies to the following records or signatures in electronic format (Part 11 Records or Signatures): The simple answer is no.

Indeed, Part 11 of 21 CFR does not only specify technical requirements. It has also put in place organizational measures. And you can`t buy them. However, manufacturers such as our sister company Medsoto have manufactured the products in such a way as to meet the technical requirements for the creation of the (technical) documentation. You can also read the rules you need to follow to comply with health regulations. Records that must be kept in accordance with the requirements of the predicate rule and that are kept in electronic format rather than in paper format. On the other hand, records (and any associated signatures) that do not need to be retained in accordance with the predicate rules, but are still kept in electronic format, are not Part 11 records. With Part 11 on electronic records; Electronic signatures The FDA has given many companies sleepless nights (and good deals to consultants), especially in the pharmaceutical sector. When using identification codes (e.g., username, initials, or number) and passwords, 21 CFR Part 11 sets out the following requirements in 11,200(a) and 11,300: The FDA`s guidelines for electronic registration and signature software are quite broad. This gives you the opportunity to implement a system that meets your 21 CFR Part 11 software requirements and offers additional benefits.

An important aspect of 21 CFR Part 11 compliant software is how 21 CFR Part 11 electronic documents are created, reviewed, approved, modified, and controlled. A strong quality system ensures that medical devices are of consistently high quality and are safe and effective for their intended uses. Regulatory requirements for the quality system are anchored in the Code of Federal Regulations, Title 21, Part 820 (21 CFR Part 820). The Agency intends to exercise enforcement discretion with respect to the specific requirements of Part 11 for the making of copies of documents (§ 11.10(b) and any corresponding requirements of § 11.30). You should provide an investigator with adequate and useful access to records during an inspection. All records you hold are subject to inspection in accordance with the standard rules (e.g. §§ 211.180 (c), (d) and 108.35 (c) (3) (ii)). It is important to note that the FDA`s exercise of enforcement discretion as described in these guidelines 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 enforce provisions regarding the following controls and requirements: In Part 11 of 21 CFR, the FDA sets out its electronic records and signature requirements, which also apply to medical device manufacturers. However, software that provides the necessary support for 21 CFR 11 compliant electronic records and signatures is likely to have robust document control capabilities, including revision tracking and audit trails. Users must be able to obtain meaningful data from the software.

In addition, we intend to exercise our enforcement discretion and do not intend to take (or recommend) action to enforce Part 11 requirements for systems that occur before September 20. August 1997, the effective date of Part 11 (commonly referred to as legacy systems), were operational in the circumstances described in Section III.C.3 of this guidance document. 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. FDA guidelines, including these guidelines, do not establish legally enforceable liabilities. Instead, the guidelines describe the Agency`s current deliberations on a topic and should only be considered as recommendations, unless specific regulatory or legal requirements are mentioned.