White Paper: FDA’s 21 CFR Part 11
White Paper: FDA’s 21 CFR Part 11
9 PagesLabforward GmbH Elsenstr. 106, 12435 Berlin, Germany www.labforward.io Contact| Labforward Team contact@labforward.io +49 (0)30 / 91572642 White Paper: FDA’s 21 CFR Part 11 1TABLE OF CONTENTS Subpart B – Electronic Records 3 Section 11.10: Controls for closed systems. 3 Sec. 11.30: Controls for open systems. 6 Section 11.50: Signature Manifestations 6 Sec. 11.70: Signature/record linking 7 Subpart C - Electronic Signatures 7 Sec. 11.100: General requirements. 7 Sec. 11.200: Electronic signature components and controls. 8 Sec. 11.300: Controls for identification codes/passwords. 8 2How Labfolder Meets Technical Requirements of FDA’s 21 CFR Part 11 Background and Introduction Title 21 CFR Part 11 of the Code of Federal Regulations contains the regulations concerning electronic records and el
