The 21 CFR Part 11 regulation has an impact on all FDA regulated industries that use computers for regulated activities. It states , electronic records can be equivalent to paper records and handwritten signatures.
However 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. 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.
This document will guide you how to integrate all requirements, procedures and documents into a single project. it provides information on
- FDA Regulations and Guidelines
- Training tools and Documentation
- Written Procedures
- Checklists, Forms, Templates
- Master Plans
- Project Team
- Scope & Control
- Communication & Training
- Part 11 Compliance for New Systems
- Part 11 Compliance for Existing Systems
- Ongoing Control
This document should serve as a framework to implement Part 11 projects within a company.
Product ID : KTCP232
Preview Sample – 21 CFR Part 11 Master Plan
Format: Editable Word document
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