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Regulatory compliance with Document Manager for Confluence

As you may have discovered in our previous communications and webinars, ADN has made available its first plug-in available on the Atlassian Marketplace: Document Manager for Confluence (DMC). It is an electronic document management system (EDM, or eDMS) for the Confluence and Jira collaborative workspaces. This plug-in was developed by our teams to respond to a problem that our customers often encounter; be able to manage quality and technical documentation electronically, promote collaboration and updates at a reasonable cost while ensuring compliance with applicable regulatory and normative requirements.

What regulatory requirements does this plug-in meet?

This plug-in makes it possible to meet many requirements of 21CFR part 820 and ISO 13485: v2016:

  • Be able to apply approval worflows to Confluence pages,

  • Identify Confluence approvers/signatories,

  • Provide users with updated versions via a public space,

  • Track modifications under Confluence,

  • Manage obsolete Confluence pages,

  • Control access and rights (read/modify/approve)

  • Uniquely identify Confluence pages with labels,

  • Manage your own versions beyond Confluence versions,

  • Automatically generate a Master Page

  • Control the distribution of Confluence pages.

It also makes it possible to meet the requirements of Annex 11 of the European GMPs or 21 CFR part 11 of the FDA thanks to its compliant electronic signature and its audit trail. In addition to allowing the updating of your documentation in a regulated way on a publication space, this EDMS also allows you to customize the nomenclature, the version number, and to request a confirmation of reading. The plugin also provides access to the history of changes to your documents and helps to monitor document editing steps. In particular, you can check the reasons for the modifications of the documents, the author of the document, the status (draft, in review, in approval, effective or obsolete for example). This plug-in also allows you to automatically create a global summary of all documents and their current status (Documentation master list)

More information needed

Don't miss this opportunity to make Agile document management easier for you!

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