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A logical approach to process validation.

M E Donawa1

  • 1Donawa and Associates Ltd., Rome, Italy.

Medical Device Technology
|February 7, 1995
PubMed
Summary

Keep it simple, stupid! (KISS) principles apply to process validation, emphasizing clear and simple documentation. This article offers a logical approach to key process validation elements for improved clarity and compliance.

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Area of Science:

  • Quality Management Systems
  • Pharmaceutical Manufacturing
  • Biotechnology

Background:

  • Quality system documentation, including policies and procedures, should be clear and simple.
  • The principle of "Keep it simple, stupid!" (KISS) is often relevant in technical documentation.
  • Process validation requires clear and understandable documentation for effective implementation.

Purpose of the Study:

  • To describe a logical approach to key elements of process validation.
  • To advocate for clear and simple terms in process validation documentation.
  • To help meet the objective of simplified quality system documentation.

Main Methods:

  • The article outlines a logical framework for process validation.
  • It focuses on simplifying key aspects of the validation process.
  • The approach aims for clarity and ease of understanding.

Main Results:

  • A simplified, logical approach to process validation is presented.
  • The proposed method enhances the clarity of validation documentation.
  • This approach aids in meeting the objective of simple and effective quality systems.

Conclusions:

  • Clear and simple documentation is crucial for effective process validation.
  • Adopting a logical approach can significantly improve the understandability of validation processes.
  • The KISS principle, when applied thoughtfully, can lead to more robust and manageable quality systems.

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