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Related Experiment Videos

Validation of automated systems--system definition.

R W Stotz1, K G Chapman

  • 1Jacobs Engineering Group, Cincinnati, Ohio.

Journal of Parenteral Science and Technology : a Publication of the Parenteral Drug Association
|September 1, 1992
PubMed
Summary

A new technical report from the Parenteral Drug Association (PDA) Committee on Software Validation will soon be released. It details a process for validating automated systems, especially those from external vendors, focusing on system definition and lifecycle management.

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Area of Science:

  • Pharmaceutical Science
  • Computer Science
  • Regulatory Affairs

Background:

  • Automated systems are increasingly used in pharmaceutical manufacturing.
  • Validating third-party vendor-supplied automated systems presents unique challenges.
  • Existing validation processes need enhancement to address complex automated systems.

Purpose of the Study:

  • To introduce a comprehensive process for software validation of automated systems.
  • To provide guidance on validating systems, particularly those with external vendor components.
  • To align validation practices with the System Development Life Cycle (SDLC) approach.

Main Methods:

  • Development of a technical report by the Parenteral Drug Association (PDA) Committee on Software Validation.

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  • Emphasis on key stages: system definition, system specification, system qualification, and ongoing evaluation.
  • Integration of concepts consistent with the Pharmaceutical Manufacturers Association's (PMA) SDLC model.

    • Main Results:

    • A forthcoming technical report outlining a structured validation process.
    • Focus on critical elements of system definition and specification for automated systems.
    • Methodology applicable to both in-house and vendor-supplied automated systems.

    Conclusions:

    • The proposed validation process offers a robust framework for automated systems.
    • Clear system definition and specification are crucial for successful validation.
    • Adherence to a lifecycle approach ensures ongoing system integrity and compliance.