I would like to know if anybody has managed to setup an FDA Part11 compliant Confluence system, e.g. for documenting medical devices. We are still working on this issue and I would be interested in sharing and discussing experiences.
Our requirements are:
We are using the latest Confluence version and the following plugins:
This is how we organize our content:
Our current challenges/ open issues:
If a document/page has been approved its content should be frozen. This means that as soon as the content is edited the document has to lose its Approved status. But how can the following issues be solved:
One idea to approach this problem is to automatically generate a PDF including information about the electronic signatures as soon as the page reaches the approved status. The PDF is static and cannot be changed easily. We would then argue that our employees should refer to the PDF files in their daily work and that Confluence is just used as a content editor. This is how we worked in the past (MS Word for editing document and generating PDFs files, which are printed out, signed by hand, scanned and archived in SVN and folders), but it is obviously not the way you would like to use a Confluence based system.
Has anybody managed to solve these issues or another idea how to approach this topic?
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