Document Status

Group Description

There is often ambiguity regarding the expectations from regulatory authorities for the identification and management of document with varying status. This would include, for example the identification and management of draft documents, documents in preparation, and copies of documents (digital copies generated from paper documents, photocopies, or digital documents converted from one digital format to another). How these different document versions are identified and managed - whether as part of the TMF or not - can have an impact on your filing structure, the metadata used within your eTMF, and overall TMF management process. This is therefore of concern to this project with regards to adoption of the Reference Model.
This team will review available regulations and guidance from agencies to produce a White Paper on various aspects of document status. This would include the handling of copies and certified copies and handling of drafts. The White Paper will be clear with regards to explicit requirements from regulatory agencies versus a consensus from industry of what is considered "best practice" in the absence of explicit requirements from regulatory agencies.

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