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.pdfhttp://misysinc.com/support/assets/pdf/MISys%20Manufacturing%20Software%20Qualification%20-%20Example%20document%20by%20JC3.pdfhttp://misysinc.com/support/assets/pdf/MISys%20Validation%20Appendix-TC-A1%20by%20JC3.pdfhttp://misysinc.com/support/assets/pdf/MISys%20Validation%20Appendix-TC-A2%20by%20JC3.pdfhttp://misysinc.com/support/assets/pdf/MISys%20Validation%20Input%20Document-TC-A2%20by%20JC3.pdf
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