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Is MISys Manufacturing ISO Certified or Validated?

Solution

While the MISys Manufacturing software by itself is not ISO certified or Validated, it is an integral part of the systems and processes used by a manufacturer to become Validated and/or ISO certified.

The link below provides you with access to documents that were prepared for a pharmaceutical company.  These can be used as a template for a customer or site to complete in order to seek this certification. 

NOTE:The first link below is the "Abridged Summary of MISys Related to ISO". This is a document that discusses various ISO requirements and how MISys meets them.

http://misysinc.com/support/assets/pdf/Abridged%20Summary%20of%20MISys%20Related%20to%20ISO.pdf

http://misysinc.com/support/assets/pdf/Description%20of%20Sample%20Validation%20Documentation%20by%20JC3.pdf

http://misysinc.com/support/assets/pdf/MISys%20Manufacturing%20Software%20Qualification%20-%20Example%20document%20by%20JC3.pdf

http://misysinc.com/support/assets/pdf/MISys%20Validation%20Appendix-TC-A1%20by%20JC3.pdf

http://misysinc.com/support/assets/pdf/MISys%20Validation%20Appendix-TC-A2%20by%20JC3.pdf

http://misysinc.com/support/assets/pdf/MISys%20Validation%20Input%20Document-TC-A2%20by%20JC3.pdf

 
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Article ID: 60
Category: General
Date added: Feb-25-2014: 11:56am
Views: 486
Rating (Votes): Article rated 3.4/5.0 (22)

 
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