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    • intro
    • Step by Step
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    • Leverage supplier documentation
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    • Intro
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Lean Validation

What is Lean Validation?

Lean Validation is defined as the delivery of validation services to customers with as little waste as possible.

Lean Validation is a combination of Lean Manufacturing and Validation. The process of Validation is described in another section of this web site. Another section describes the Lean Manufacturing principles. This section describes how to apply the Lean Manufacturing principles on the Validation process to get the best balance between Quality and Efficiency

If you look at validation from a Lean point of view two Japanese words often apply.

  • muda (non-value-adding work).
  • muri (overdoing)

An example of muda is given under Change Control where a lot of signatures are written on documents without adding value to the quality of the change. Finding muda starts with describing the process with Value Stream Mapping.

Muri is often applicable in the verification process of Validation. The same object is tested multiple times. Leveraging supplier documentation is a solution for this.

A number of solutions to improve efficiency in Validation are described in this section of the website, while the background of the principles is described in other sections of this site. If you don't know where to start with Lean Validation go to the section step by step.

 

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News

  • GMP Compliant MES Systems
  • Validation, GAMP and 21CFR11
  • ISPE GAMP document overview
  • Differences
  • The supporting processes

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