In 1997, the Food and Drug Administration (FDA) issued Part 11 of Title 21 defining the criteria under which electronic records and signatures are considered equivalent to paper records and handwritten signatures. As much controversy and confusion this regulation has caused over the years, it will actually make your life easier and clutter-free by creating a compliant and paperless quality management system.Continue reading What is 21 CFR Part 11?
MadgeTech Blog — 21 CFR Part 11
Gone are the days of having to manually record and document critical points of a product throughout its lifecycle. In this modern day and age, technology can verify that a controlled environment has been consistently maintained to preserve and protect sensitive products from manufacturing through distribution. To accommodate these technological advances, government agencies have established regulations to supervise a world that’s gone paperless.Continue reading Compliance and the Importance of Audit Trails in Life Sciences