What is the FDA 21CFR Part 11
The United States Food and Drug Administration (FDA) has a legal responsibility to ensure that medical devices are safe and effective. Therefore, in FDA-regulated industries, quality and accountability standards are much higher. One of the ways the FDA ensures quality in the industry is by requiring that records be kept of important aspects of the design, development or manufacturing process. These regulations initially dealt with printed and handwritten signatures. However, with the rise of computer technology used in the development of medical devices, it became apparent that regulations were needed to address issues related to electronic records and signatures.
Requirements for electronic records and signatures, resulting in Title 21 of the Code of Federal Regulations; in particular Part 11 – Electronic Registration. Electronic Signatures Regulation (21 CFR Part 11) enacted in August 1997. The purpose of 11CFR Part 21 is to enable the industry to take advantage of electronic record keeping, while ensuring that electronic files and signatures are equivalent to printed files. and signatures.
The regulation sets out what the FDA requires to ensure that online registrations are reliable, trustworthy and authentic and that they can be considered equivalent to paper registrations and handwritten signatures for FDA purposes. This rule does not require the use of electronic files. However,
Three main types of FDA requirements 21CFR Part 11
21 CFR Requirements Part 11 can be classified into three types: policy, procedural and technical. All three types of regulations are based on each other and must all be implemented in order to have a truly compliant system. The policy and procedure regulations provide the basis for compliance and set out both the intent and the criteria for using the system. While we can define the functions that make Visure Requirements comply with technical requirements, it also covers the policies you implement and how your employees interact with the software.
The policy requirements within an organization cover the interpretation of the regulation by the company, how the company will verify the identity of individuals and how to ensure the validity of electronic signatures. These include setting a policy for:
Record protection to allow accurate and ready retrieval throughout the file retention process
Restriction of system access to authorized persons
Use operating system controls to enforce permitted sequences of steps and events
Determining that the people who develop, maintain and use the system have the appropriate education, training and experience
Written policies to hold individuals accountable for things they have agreed to do to prevent fraud in company records and signatures and that individuals are responsible for actions that begin under their electronic signatures.
Procedural requirements are the company’s standard operating procedures (SOPs) for a system – the instruction documents. There should be SOPs related to IT infrastructure, addressing areas such as data backup, data security, computer system validation, alerts, training, and other aspects of computer systems that support electronic registrations and signatures.
When the company using it uses a built-in regulatory policy and fully implements the required procedural controls, it can then install and release a software application to manage the technical controls. Part 11 allows the replacement of any paper record with an electronic record, provided the computer system has the appropriate features and is validated. CFR 21 Part 11 requires electronic signatures to be accompanied by a detailed history of the document – a trace of control. The goal is to show responsibility and have the story come back at any time to see what the condition of this record was. People who use closed systems to create, modify,
Using a FDA 21CFR Compliance Clause Management Tool Part 11
This White Paper describes the Visure Requirements solution to meet FDA 21CFR Part 11 requirements in one-of-a-kind shelf management applications (COTS). Visure Requirements is one of the most flexible, powerful Engineering Requirements support tools developed by Visure Solutions. Visure Requirements is not only a requirements management tool, but also provides full support for the Engineering Requirements process, through a number of features that allow you to perform the basic activities associated with this process. It also provides the necessary support for other complementary activities, such as:
Change impact analysis.
Reuse the requirement specification .
Visure Requirements is ideal for companies and organizations in medical, medical devices, pharmaceuticals, high process, advanced technology, manufacturing and other industries highly regulated by the FDA.