Electronic Records and Signatures - 21 CFR Part 11 : Basic Concepts

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This Book "Electronic Records and Signatures - 21 CFR Part 11 : Basic Concepts"will introduce you to key components of a computerized system validation master plan and set out the requirements for compliance as per FDA’s 21 CFR 11. It will detail several aspects such as requirements, design, configuration specifications, validation testing, procedures/archival/traceability, and best practices for system decommissioning/retirement as well.

Why should you get this manual :

The comprehensive testing and control of computerized systems is first and foremost a matter of business continuity. The industry is absolutely dependent upon the reliability and accuracy of these systems for daily operations. Short of fire or catastrophic natural disasters, nothing is more disruptive to business continuity than the dreaded phrase, “the system is down.” A well designed validation project will provide assurance of business continuity, and consequently provide assurance of regulatory compliance.

This presentation will diminish the mystery associated with computerized system validation, provide readers with a clear understanding of the basic concepts of validation, and describe the steps to be taken by a project team leading to a well-controlled and successful computerized system validation.

Learning Objectives:

  • Subpart A: General Provisions
  • Subpart B: Electronic Records
  • Subpart C: Electronic Signatures
  • Scope & Application Guidance

Who Will Benefit:

Project/strategic management, Quality assurance staff, IT staff, Operations staff, Staff members involved with computerized system validation project planning, validation testing, system use, system support, and regulatory compliance of computerized systems

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