Following the coming into force of Part 11 in August 1997, important discussions ensued between industry, contractors and the Agency on the interpretation and implementation of the rules. The FDA has (1) discussed Part 11 at numerous conferences and has repeatedly met with a coalition of industry and other interested parties to learn more about possible Part 11 issues. (2) published a Compliance Guidelines Guide, GIC 7153.17: Enforcement Policy: 21 CFR Part 11; Electronic records; Electronic signatures; and (3) has issued numerous draft guidelines, including the following: 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): (2) The document or parts of a document to be submitted have been listed in Public Record No. 92S-0251 identified as the type of submission that the Agency accepts in electronic form. That file shall specify exactly which types of documents or parts of documents may be submitted in electronic form without paper files and which unit(s) of the Agency (e.g. centre, office, department, specific branch) to which such tenders may be addressed. Documents addressed to the receiving agency or agencies of the agency or agencies that are not specified in the public file shall not be considered official if they are submitted in electronic form; The paper forms in these documents are considered official and must be attached to all electronic records. Individuals are expected to contact the recipient point of the organization to find out how (e.g., Method of delivery, media, file formats and technical protocols) and if necessary electronic transmission. With the requirements discussed earlier, medical product manufacturers can create CFR Part 11 compliance checklists to ensure the security and integrity of their digital documents.
However, this can be challenging, especially as the company moves from paper to digital. We understand that there is some confusion as to the scope of Part 11. Some have understood that the scope of Part 11 is very broad. We believe that some of these general interpretations could lead to unnecessary controls and costs and prevent innovation and technological progress without adding value to public health. We would therefore like to make it clear that the Agency intends to interpret the scope of Part 11 narrowly. The FDA does not intend to raise any objections if you decide to archive the required documents in electronic format on non-electronic media such as microfilm, microfiche and paper, or in a standard electronic file format (examples of such formats include PDF, XML or SGML). Individuals must continue to comply with all the requirements of the predicate rule, and the documents themselves and all copies of the required documents must preserve their content and importance. As long as the requirements of the predicate rule are fully met and the content and meaning of the records are retained and archived, you can delete the electronic version of the records. In addition, paper and electronic registration and signature components may coexist (i.e. a hybrid situation8), provided that the requirements of the predicate rule are met and that the content and meaning of these records are preserved. Life science manufacturers have a set of FDA requirements that include essential quality management considerations when implementing digital document management systems.
These include: Many companies print everything on paper and then sign it by hand to bypass part 11 requirements. Is it really necessary? The “Electronic Records” section sets out the requirements for managing closed and open electronic record systems, and then discusses signature manifestations and requirements for linking signatures to records. The requirements of Part 11 of 21 CFR apply to software (both “open systems” and “closed systems”) used to implement part of a quality system. The 21 CFR Part 11 checklist includes, but is not limited to: The FDA also specifies audit trail requirements in this section, similar to the document control requirements of 21 CFR Part 820. Medical device companies must maintain adequate control over system documentation, including review and change control procedures, in order to maintain an audit trail that documents changes to the system. An audit trail ensures that any activity that takes place in the registration system can generate a record and be reviewed later. 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)). 21 CfR Part 11 refers to Part 11 of Title 21 of the Code of Federal Regulations as determined by the United States Food and Drug Administration.
These regulations focus on electronic records (including electronic batch records and device history records) as well as electronic signatures, and provide conditions under which these specific compliance activities can be approved to the same extent as signatures on paper documents. 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. Consider other opposing methods to approach this process. Companies that use paper-based systems must manually monitor these operations, ensuring complete accuracy and efficiency in document control and security-based activities. Doing it this way requires a lot of effort, not to mention the myriad of risks associated with the likelihood of human error. 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. 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. In the 21 CFR Part 11 Summary, all records stored and managed electronically from the quality system fall under FDA 21 CFR Part 11 compliance. The requirements of 21 CFR Part 11 cover electronic documents. 21 Compliance with Part 11 of the CFR applies to both in-house developed computer systems and ready-to-use commercial software. The basic idea of the requirements of Part 11 of 21 CFR and the software requirements of Part 11 of 21 CFR is that electronic documents must be protected from modification without specifying who changed them. Yes, you do. Please note, however, that the FDA has slightly relaxed the requirements of the audit study.
The protests were too large. Operational Controls: In Part 11, the FDA specifies that manufacturers use operating system tests to apply the permissible sequence of steps and events, if any. Part 11 states that electronic signatures applied to documents must include the printed name of the signatory, the date and time the signature was applied, and the “service” or intent of the electronic signature as part of an evolving, non-modifiable audit trail. But the demands don`t stop there. This means that each Software that complies with Part 11 of 21 CFR must have security measures (using individual usernames and security credentials) in an accessible, computer-generated, time-stamped audit trail that indicates who did what and when, as well as a way to record electronic signatures. 21 CFR Part 11 offers medical device companies the opportunity to take advantage of the organizational benefits of paperless registration systems. It also helps the FDA ensure that when medical device companies use electronic registration systems, the security and authenticity of documents are properly maintained. Building on its current Good Manufacturing Practices (GMP) initiative for drugs and human and veterinary biologics4, the FDA is reviewing Part 11 as it applies to all FDA-regulated products. We anticipate that, as a result of this review, we will begin to develop rules to amend Part 11.