ComplianceOnline

Part 11 Compliance Master Plan

The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP).

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  • With this regulation, titled Rule 21 CFR Part 11 , electronic records can be equivalent to paper records and handwritten signatures.
  • The rule has an impact on all FDA regulated industries that use computers for regulated activities.
  • 21 CFR Part 11 does not stand on its own. It always refers to the predicated rules (GLP, GMP, GCP, Food and others) and requirements for Part 11 include many activities already going on within an organization.
  • A security master plan describes a company's approach to ensure security and limited and authorized access to buildings, critical areas within buildings.
  • This document helps to integrate all requirements, procedures and documents into a single project.
  • When new systems are purchased, Part 11 requirements should be defined for the systems. The requirements should be specified together with other requirements in a User Requirement Specification (URS) document.
  • These are requirements that are listed in 21 CFR Part 11 and have not een affected by the FDA's new approach.

It Provides information on:

  • FDA Regulations and Guidelines
  • Master Plans
  • Project Team
  • Part 11 Compliance for New Systems
  • Part 11 Compliance for Existing Systems
  • Ongoing Control

 

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