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Post by Admin on Sept 22, 2016 15:27:32 GMT
Dear Pocket EDMS fans,
Version 4.0 of the User Requirements Reference Model for EDMS in Small Pharma (Pocket EDMS) was released to the public several months ago and during this time we have collected valuable feedback both on the text itself and on the practical aspects of the implementation process. We are now happy to introduce Pocket EDMS version 5.0 (released on 21 September 2016) which incorporates important improvements and additions.
As always, all the material pertaining to Pocket EDMS are made available for free as this is the result of a a collaborative effort for the good of the industry, by the industry and free to the industry. There is no obligation to use this model but we believe that it carries substantial value for many of us. We have made a conscious effort to avoid ANY bias towards any vendor but the model does provide a minimum set of requirements to meet current compliance requirements in the Life Sciences industry worldwide. All material can be downloaded at www.pocketedms.wordpress.com and you are welcome to share your thoughts and comments with other users on this forum.
Pocket EDMS is linked to the DIA EDM Reference Model and as a natural progression, we are collaborating with the DIA TMF Reference Model committee to include requirements for Clinical Trial Master File solutions, (Pocket eTMF). These will be published as an extension to the Pocket EDMS specifications later this fall.
We hope that you will find the model clear and useful
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seif
New Member
Posts: 1
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Post by seif on Feb 7, 2017 10:45:20 GMT
When the URS including eTMF (V6.0) will be published ? Additionnaly Vendor selection procedure is in place but can't find it ? thanks for reply and help
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Post by Dimitri Stamatiadis on Aug 24, 2017 14:48:17 GMT
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