What is 21 CFR Part 11?
In our digital era, FDA-regulated industries are supposed to be confident that their e-records and signatures are no less reliable than paper ones. It is here that 21 CFR Part 11 is used. It is an essential regulation developed by the U.S Food and Drug Administration (FDA) that establishes the specifications in and under which electronic records and electronic signatures are trusted trustworthy, dependable, and practically indistinguishable to paper records.
Understanding 21 CFR Part 11
21 CFR Part 11 belongs to Code of Federal Regulations (CFR), Title 21 that deals with food and drugs. This regulation was enacted in 1997 and covers all the FDA regulated industries such as pharmaceuticals, biotechnology, medical devices biologics, and contract research organizations (CROs).
This regulation is mostly aimed to protect a product and data integrity through the assurance of electronic records and electronic signatures being secure, authentic, and compliant.
Key Requirements of 21 CFR Part 11
To meet 21 CFR Part 11, some of the controls that organizations must employ include:- System Validation: To assure proper software and system utilized to maintain electronic records are accurate, can be relied upon and perform in a predictable manner all systems and software are validated.
- Audit Trail: Systems are required to produce a computer-generated time stamp audit trail that documents the identity and actions of personnel who create, modify, or delete electronic records.
- Electronic Signatures: They must be individual and must be equal to handwritten signatures. They should be safeguarded so as to avoid misuse.
- Access Control: There should be tight security control of access to authorized users.
- Record Retrieval and Retention: Electronic records should be easily retrieved and stored as long as necessary as stipulated by the relevant rules.
Why is 21 CFR Part 11 Important?
Part 11 compliance is not just because of avoiding regulatory penalties but also to maintain data integrity, product quality, and public faith. When the lives of humans are involved like in pharmaceuticals or medical devices, then having accurate and reliable electronic records is not up to a negotiation table.
Non-compliance with Part 11 may result in warning letters from the FDA, individual legal liability, and product recalls all of which could negatively affect the reputation and bottom line of a company.
Digital Transformation
As cloud-based systems and digital transformation have entered life sciences, 21 CFR Part 11 compliance has become even more crucial. Firms need to make sure that their digital systems including Laboratory Information Management Systems (LIMS), Electronic Laboratory Notebooks (ELNs), and Document Management Systems (DMS) are compliant with Part 11.
At Masuu Global we realize the intricacy of regulatory adherence within the digital domain. Some of our solutions serve data integrity, audit trail, and validation to assist clients to pre-empt regulatory requirements.
Part 21 CFR Part 11 is not simply a regulation, but a basis of digital trust in industries subject to FDA regulations. Compliance assists in safeguarding patients, maintaining the quality of products and gaining clientele confidence with the regulatory bodies.
Seeking a reliable dependent to help your Part 11 compliance process? Call Masuu Global now to understand the compliance-based technology we offer.