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ISO 9001 KPIs for the documentation department in the pharmaceutical industry

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Guest user Created:   Oct 26, 2020 Last commented:   Oct 26, 2020

ISO 9001 KPIs for the documentation department in the pharmaceutical industry

How can I determine ISO 9001 KPIs for the documentation department in the pharmaceutical industry?

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ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Carlos Pereira da Cruz Oct 26, 2020

Start by the end!

What is the purpose of a documentation department in the pharmaceutical industry?

That department exists to meet what desirable results?

That department exists to avoid what undesirable results?

For example:

  • The documentation department exists to provide approved documents required for introducing new products in the market
  • The documentation department exists to ensure that updated documents are used where they are needed

As KPIs you can use for this example:

  • Rate of new product introductions delayed because of missing approved documents
  • Number of outdated documents found in use during audits 

The following material will provide you more information:

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Oct 26, 2020

Oct 26, 2020

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ISO 9001 Clause 8.2.3.2