The United States Food and Drug Administration (FDA) has a legal responsibility to ensure that drugs are safe and effective. Therefore, in FDA-regulated industries, quality and accountability standards are high. One of the ways the FDA assures quality in the industry is to require that records concerning important aspects of the manufacturing process be kept.
The objective of 21 CFR Part 11 regulations is to allow industry to take advantage of electronic record keeping while making sure that electronic records and signatures are equivalent to paper records and signatures. The regulation defines what the FDA requires to ensure that electronic records are reliable, trustworthy, and authentic and that they can be considered equivalent to paper records and handwritten signatures for FDA purposes. This rule does not mandate the use of electronic records; however, if electronic records are used to keep FDA-required information, then the electronic records must comply with 21 CFR Part 11.
Similar to the FDA’s 21 CFR Part 11, the European Union’s EudraLex Volume 4 Annex 11 (“Annex 11”) provides guidance for the use of computerized systems within GMP-regulated activities in EU directives. The objective of Annex 11 is to ensure that when a computerized system is used, the same product quality and quality assurance can be achieved as manual systems with no increase in the overall risk. Although Annex 11 is not a regulation, it is a guideline and is key to compliance with GMP principles in EU directives covering human and veterinary medicinal products.
This white paper illustrates how Bio4C Orchestrator™ Software provides technology to support requirements for electronic records and provides a detailed “rule-by-rule” analysis for 21 CFR Part 11 and Annex 11 in tabular form.