Complying with Electronic Record Requirements

Montrium, a consulting company, says that technology and computerized systems have changed the way that lifesciences companies do business. Such a transition has been accompanied by an additional expectation of complying with various regulations, it says. A white paper focuses on FDA’s legal requirements for electronic records and signatures, and the European Union’s regulatory requirements for computerized systems. The paper analyzes the similarities and differences between the two directives with an eye to recommending a standard approach to demonstrate compliance with each.

Steps in its approach to achieving compliance include: (1) perform a gap assessment; (2) plan and implement mitigation activities; and (3) validate the computer system following the International Society for Pharmaceutical Engineering GAMP 5 (Good Automated Manufacturing Practice) approach.