Compliance with the Regulatory Requirements According to US FDA 21 CFR Part 11 with CIM Database
If electronic document systems in regulated industries such as the pharmaceutical industry or medical engineering industry are to replace paper-based documentation, these documentation systems must comply with the requirements of the regulatory authorities. In the USA, the Food and Drug Administration (FDA) is responsible for defining and monitoring these regulatory requirements. With an export rate of over 65 percent in Germany's medical engineering industry (source: 2016 industry report published by the German Medical Technology Association (BVMed)) and the FDA's global dominance as a regulatory authority, there is no getting around FDA regulations for companies operating in this market. CIM Database was therefore evaluated according to these requirements as a service to our customers. This document describes the functions that provide technical compliance with 21 CFR Part 11. The examination is based on the detailed requirements and also implicitly takes the requirements of Annex 11 of the EU GMP Guideline into consideration. The results of this evaluation will be published together with this document. In addition, this White Paper also documents the way in which CIM Database provides users with support for validation.