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21 CFR Part 11 Whitepaper

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 much higher. 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.

Table of Contents

  • Introduction
  • 21 CFR Part 11 and Annex 11 Controls
  • Summary

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The objective of 21 CFR Part 11 is to allow industry to take advantage of electronic recordkeeping 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 (EU)’s Annex 11 provides guidance for the use of computerized systems within Good Manufacturing Practice (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 with manual systems, with no increase in 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 the LANEXO® Inventory Manager provides technology to support requirements for electronic records. The body of the white paper provides detailed “rule-by-rule” analyses of 21 CFR Part 11 and Annex 11 in tabular form in the next section. The Customer / end user organization is responsible for determining 21 CFR Part 11 / Annex 11 requirements based on their intended use of the LANEXO® Inventory Manager in the regulatory environment and for ensuring requirements are met, tested, and verified. This document is provided as guidance information for Customers.


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