21 CFR Part 11 Explained

With more and more manufacturing companies going paperless, the FDA created a set of rules regarding electronic signatures. The final set of guidelines known as 21 CFR Part 11 were put forth in May, 2007. Any individual using electronic systems in a FDA regulated manufacturing facility is required to follow the following procedures to be in compliance with 21 CFR Part 11:

  • Validation of the system to ensure accuracy, reliability and consistency.
  • Limited access to the system to only authorized individuals.
  • Use of accurate, computer-generated time stamped audit trails ro record the time and date of operator entries, changes and deletions.
  • use of system checks to ensure proper sequencing of steps and events.
  • use of authority checks to ensure the system is only accessed by authorized individuals.
  • Use of device checks to determine the validity of the data recorded.
  • Determination that the individuals maintaining and using the system have the proper training and education.
  • Establishment of written policies that hold individuals accountable for actions initiated under electronic signatures.
  • Use of appropriate controls for the distribution and access to the system.
  • Use of appropriate controls for revisions and maintaining a proper audit log.

These regulations are meant to control security, audit trails, electronic signatures and copies for inspection. InstantGMP MES covers all of these steps making compliance with 21 CFR Part 11 easy and accurately.

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