Requirements defined in Regulation (EU) No 910/2014 and implementation of OFTP2 and FDA 21 CFR Part 11
A multitude of laws, guidelines and directives regarding consumer protection, product liability, environmental and quality management mean that companies in regulated industries have to meet stringent regulatory requirements – this applies not only to the financial industry but also to the automotive, air transport, energy, health care, life science and pharmaceutical industries. Companies in these industries therefore have to commit considerable resources to ensuring that processes meet these requirements in a traceable manner and providing appropriate certification, as well as guaranteeing that contracts are legally valid. After a brief definition of the terminology used and a description of how digital signatures work, this white paper discusses the legal specifics of digital signatures. This is followed by an introduction to two directives from regulated industries that stipulate the use of digital signatures, namely the OFTP2 transfer protocol and 21 CFR Part11. Finally, this white paper describes the possibility of integrating digital signatures in PLM processes and the resulting benefits for companies.