21 Cfr Requirements
At times, the requirements were interpreted so exaggerated that the FDA was forced to publish the guidance document: “Part 11, Electronic Records; Electronic signatures — scope and application” for explanation. In the end, it saw its own purpose, namely the use of Part 11 to create a basis for replacing paper documents with electronic information, thwarted. In all of these submissions, concerns were raised that certain interpretations of the requirements of Part 11(1) would unnecessarily restrict the use of electronic technologies in a manner consistent with the FDA`s stated intention to issue the rule, (2) significantly increase the cost of compliance to an extent that was not considered at the time the rule was drafted, and (3) preventing innovation and technological progress without bringing significant benefits to public health. These concerns were expressed particularly in the areas of Part 11 requirements related to validation, audit trails, record retention, copying of records, and existing systems. 21 CfR Part 11.30 imposes additional requirements on open systems. This includes measures such as encrypting documents and using digital signature standards to ensure the authenticity, integrity and confidentiality of records. Many companies print everything on paper and then sign it by hand to get around the requirements of Part 11. Is it really necessary? The requirements (for IT systems) must be met when documents generated, stored, submitted or modified are used to demonstrate compliance with regulatory requirements, such as: The Agency intends to carry out a law enforcement measurement against the specific requirements of Part 11 for the validation of computerised systems (§ 11.10(a) and corresponding requirements in § 11.30). Although individuals must still meet all applicable requirements of the predicate rule for validation (p. e.g., 21 CFR 820.70(i)), these guidelines should not be read in such a way as to impose additional validation requirements. While there are no default rule requirements, such as documenting the date, time, or sequence of events in a particular case, it may still be important to have audit trails or other physical, logical, or procedural security measures in place to ensure the reliability and reliability of records.6 We recommend that you base your decision on the application of audit trails. or other appropriate measures concerning the need to comply with the requirements of the predicate rule, a reasoned and documented risk assessment and a determination of the potential impact on product quality and safety, as well as on the integrity of records.
We recommend that you carry out the appropriate checks on the basis of such an assessment. Audit trails can be particularly useful if users are expected to create, modify, or delete regulated records during normal operation. 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 can contribute to: Q: What are the documentation requirements for 21 CFR 11 compliant programs? A: There must be documentation that defines the operation and maintenance of the system. As a rule, these requirements are met by the company`s document control procedures. Additional information on document control systems The Agency intends to exercise its discretion with regard to the specific requirements of Part 11 for the making of copies of documents (§ 11.10 (b) and a corresponding requirement in § 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)). 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. The requirements of Part 11 of the 21 CFR regarding digital signatures will seem familiar to anyone who has already dealt with this topic, and for example the German Signature Act: Part 11 specifies the control you need over access and editing rights in your system. The regulation contains many strict requirements to prevent accidental loss and deletion of data, as well as security breaches that can lead to customer damage, business failures and fines from regulators. A first option would be to scan a signature, insert it into the document and print it in PDF format. But this would not meet the requirements of Part 11.70. You can export this graphic as a screenshot and paste it into another document. Q: What are the requirements for electronic signatures? A: All electronic signatures must: The requirements for open and closed systems are different. A system is closed when it is under the control of persons responsible for the electronic records managed by that system. Otherwise, it is an open system. The requirements described in Subsection C on Electronic Signatures are as follows: We suggest that your decision to retain records be based on the requirements of the predicate rule and that you base your decision on a reasoned and documented risk assessment and determination of the value of documents over time.
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. For more information on the education, training and experience required for 21 CFR 11, the Agency intends to exercise its discretion with respect to the protection requirements of Part 11 to enable their accurate and operational availability throughout the retention period of records (§ 11.10(c) and any corresponding requirements of § 11.30).