What is 21 CFR 11?

The basic requirement of the Electronic Records; Electronic Signature final rule (21 CFR 11) legislation is to ensure that any computerized system used for regulatory purposes produces electronic records that have integrity and reliability, and that electronic signatures are trustworthy and equivalent to handwritten signatures executed on paper records.

• 21 CFR Part 11 was created to address the increased use of electronic records in the Pharmaceutical industry and to promote the use of electronic technology.
• 21 CFR 11 contains the requirements for ensuring that electronic records and electronic signatures are trustworthy and reliable.
• If a drug maker/medical manufacturing company chooses to maintain records in electronic format instead of paper format, those records are subject to the rules of 21 CFR Part 11.

Advanced colour touchscreen controllers

Astell is one of few autoclave manufacturers able to provide controller software that conforms to FDA 21 CFR Part 11. The fundamental requirements of 21 CFR 11 are the compliance with Data Security, Data Integrity, Traceability/Audit Trails and Electronic Signature rules. In the case of sterilizers, this means any change made to a cycle, option, or device parameter will require an electronic signature. All device changes and signatures will be electronically logged and can be recalled to provide a clear picture of user input for any given point in time. All audit trails are saved in a file format that cannot be altered in any way.

To achieve this level of compliance requires a dynamic and robust controller, such as the colour touchscreen system Astell provides on every one of its sterilizers. By incorporating all device settings in to one electronic interface users have the necessary control and security at their fingertips.

For more information on FDA 21 CFR Part 11 autoclave software options please Contact us.