How Kneat Meets 21 CFR Part 11 and Unlocks Additional Benefits
As life sciences manufacturers continue to seek efficiencies in processes through computer systems, demand to install and maintain an array of increasingly complex computer systems and software grows, as does risk profile. The U.S. FDA’s 21 CFR Part 11 regulation—which determines the validation and compliance of electronic systems—helps companies by setting out broad definitions and rules, supported by extensive guidance.
In this article, we outline how Kneat helps you to reach compliance with the regulation while unlocking additional benefits for validation professionals, such as enhanced data integrity and smarter documentation collaboration and control.
21 CFR Part 11 Compliant Software
Compliance with FDA regulations is a market requirement for the life sciences industry. It is the responsibility of the organization itself to ensure that it follows 21 CFR Part 11. Failure to comply can be very expensive—and can lead to product recalls, significant reputational damage, and even criminal penalties.
21 CFR Part 11 compliant software includes GxP critical systems that meet the FDA's requirements for the acceptance of electronic records and electronic signatures. These standards look to ensure that electronic records and signatures used in a company are equally, or arguably, more trustworthy and reliable as paper equivalents.
21 CFR Part 11, s.11.3 defines “electronic record” to mean; “any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.”
It is important to note that this broad definition means that even companies using any partly paper-based validation processes must nevertheless comply with the regulation, if their current system involves scanning and uploading any document to a server. You can learn more about the regulation’s requirements, relevant sections, and descriptions in this 21 CFR Part 11 Fact Sheet.
When digitizing validation records, it's important to look beyond simply achieving compliance to select and apply systems that help you build a modern, data-centric approach to your validation program while offering broader value creation.
What are the Technical Features Needed for 21 CFR Part 11 System Compliance?
At a minimum, the technical features needed for system compliance with 21 CFR Part 11 are:
- Security and access levels
- Audit trails
- Electronic signatures/biometrics
- Control of sequence of events
- Data protection/integrity
Security and Access Levels
These are important to ensure that unauthorized people can’t access the system. And when accessing the system, the level of access within needs to be controlled as well. Security controls for user identification in Part 11 compliant systems must have password and security features that limit user access and their privileges.
Kneat’s User Administration area allows authorized administrators to create, edit, and deactivate role-based user accounts. All users, user permissions, and the creation of user groups to suit processes are managed in this area of Kneat, allowing you to assign and manage user permissions from one centrally controlled panel and assign user privileges as needed.
... to continue reading, head over to the full article on our Kneat blog.