Medical Device Manufacturers and CFR21 Part 11

Posted July 15, 2019

CFR21 Part 11 is a part of the Code of Regulations, Title 21, which has established the regulations for electronic signatures and records for the United States Food and Drug Administration. Any company that uses electronic systems for signature control and documents must be compliant to CFR21 Part 11. This shows that the documents in electronic form are authentic. Regulations also provide for the confidentiality of these electronic records.

Medical device businesses must comply with the guidelines presented in this regulatory landscape. Basically, software validation is required in addition to validation in the design and manufacturing of medical devices. Computer systems must be using software that ensures that these important compliance regulations are being met.

Technology continues to advance in the medical device field every day and it’s important to have digitalization of all compliance records and documents and the automation of the processes involved. Systems must be developed that understand the validation requirements of CFR21 Part 11.

The compliance regulations have been created to keep the integrity of the data systems safeguarded while at the same time ensuring the validity and the safety of electronic signatures. Medical devices rely on the assurance of data integrity.

Companies must maintain specified records in a secured fashion and then submit data as needed to the FDA as part of the overall compliance. Validation for Part 11 is required for systems that modify, create, maintain, transmit or retrieve electronic records.

The computer software system that you use must be chosen based on the input it will have on the integrity, reliability, city, availability and authenticity of the signatures and records you’ll be keeping. For a free demo of the best compliance software available on the market for medical device manufacturers please visit today.