Is Digital Signature really necessary for an open system considered by FDA’s 21 CFR Part 11?
21 CFR Part 11’s Subpart B for Electronic Records has a section on ‘Controls for Open Systems" stating that:
Persons who use open systems to create, modify, maintain, or transmit
electronic records shall employ procedures and control… Continue reading Is Digital Signature really necessary for an open system considered by FDA’s 21 CFR Part 11?