Software in Medical Devices, by MD101 Consulting - Validation of software used in production and QMS - Part 2 Validation Master Plan - CommentsBlog about software medical devices and their regulatory compliance. Main subjects are software validation, IEC 62304, ISO 13485, ISO 14971, CE mark 93/42 directive and 21 CFR part 820.2024-03-27T15:32:28+01:00Cyrille Michaudurn:md5:9c06172e7cd5ed0f5b192883b657eabbDotclearValidation of software used in production and QMS - Part 2 Validation Master Plan - Mitchurn:md5:f1be81fe7fc9af67e34b58536d2654262016-09-19T02:18:38+02:002016-09-19T01:20:24+02:00Mitch<p>Thanks for your feedback!</p>
<p>I don't have such templates, unfortunately. </p>Validation of software used in production and QMS - Part 2 Validation Master Plan - Jamesurn:md5:6af1bd9a64bfb58d86edf3d7a9bbc5c12016-09-18T01:27:19+02:002016-09-19T01:17:03+02:00James<p>Hi Mitch,</p>
<p>You are spot on with the article. I am interested in understanding more broader software validation where ERP, QMS and AERS are intergrated, also requires Infrastructure validation , Do you have template for that type of software validation system. If you can share VMP template for more complex and prop software like trackwise, oracle or sap would be great help for us. I appreciate if you can share your thoughts and templates on it.</p>
<p>Thanks<br />
james</p>