B Medical Systems technical briefing on Part 11 electronic records compliance

white-paperB Medical Systems
December 17th 2020

B Medical Systems, the Luxembourg-based pioneer in the medical equipment industry, has published a paper on the scope of CFR Part 11 and how °B Connected, a remote monitoring solution developed by B Medical Systems is in conformity with the standards set by 21 CFR.  Part 11 excluding electronic signature (Subpart C).

Commonly known as ‘Part 11’ the code applies to Pharmaceutical companies, medical device manufacturers and all the other FDA regulated industries. It describes the technical and procedural requirements that must be met if an organization chooses to maintain records electronically and uses electronic signatures.

Part 11 also connects to compliance with wider standards such as Good Clinical Practice (GCP), Current Good Manufacturing Practice (GMP), calling for enforcement of all predicate rule requirements, including predicate rule record and recordkeeping requirements.

B Connected compliance

The downloadable White Paper oB Connected – Remote Monitoring Systems from B Medical Systems and Compliance to 21 CFR Part 11, explains the scope of CFR Part 11 and provides an overall guide to the Part 11 criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.

The paper aims to help resolve widespread industry confusion related to the scope of usage and applicability of 21 CFR Part 11 in day-to-day operational scenarios and specifically show how the oB Connected remote monitoring solution developed by B Medical Systems conforms with the key Part 11 Subpart B standards, relating to Electronic Controls.