New in version 7.0: TMF requirements. New numbering system. Requirement reordered to separate mandatory from optional. Bug fixes (yes there were a few!). Glossary.
Download the latest Pocket EDMS – ETMF URS (May 2017): Pocket EDMS ETMF URS v7.0
Download the French version of the URS:EDMS URS detailed v7.1_FR
Stay tuned for more updates after the first eTMF implementations!
- Suggestions that did not make it in the URS: Change Log for URS 4.0 16mar2016
- Participating Vendors can provide profile information: Vendor Presentation
- Sponsors can use these to make their selection: Selection Sheet v7
- A forum where you can discuss with others: http://pocketedms.freeforums.net
Why Pocket EDMS?
It is understood that small organisations do not have the resources (human or financial) and frequently even lack the necessary knowledge and experience for selecting an EDMS through a classic detailed procedure. Furthermore, small companies may not be able to bear the cost of a traditional system hosted and maintained on premises. As a result, the proportion of small companies that posses and use such systems today is low, in comparison to larger organisations.
However, recent innovation has led to dramatic reduction of the cost and burden of ownership of an EDMS and the development of standards has greatly simplified the setup procedures. Finally, regulatory agencies have recently announced the definitive ban of paper submission dossiers, making the use of an EDMS a quasi-obligation.
Without the burden of a classic selection process, implementing such a package is possible for small companies at a fraction of the traditional cost. There is also an interest for software vendors who currently spend a lot of time and energy answering similar questions repeatedly.
So what is Pocket EDMS and how does it work?
Pocket EDMS is a reference EDM and eTMF implementation protocol for small sized companies. Pocket EDMS is based on a Universal Requirements Specifications set including, Users, System and Quality/Regulatory Requirements. It also includes a Q&A document (replacing the traditional RFI – Request for Information) and a set of notation tools allowing sponsor companies to easily evaluate vendor proposals.
In order to qualify for Pocket EDMS/eTMF implementation, a package must provide capacity for Electronic Document Management including Quality documentation and Electronic Trial Master Files, with extensions to Publishing / ECTD and Regulatory Information Management. It must be priced according to the limited needs of small companies and be based on existing standards (EDM Reference Model, GMP Quality Systems Reference Model, TMF Reference Model…) as described in the Pocket EDMS specifications.
The Pocket EDMS Requirements Specifications are the result of collaboration from a large number of contributors. They are aimed at streamlining the implementation process by removing all the steps that do not constitute a field of differentiation between software packages. Thus, competition is limited to price and services offered by the participant vendors.
What is our role in Pocket EDMS?
MAIA Consulting, the Scribner Group, the Scientific Archivists Group (SAG) and the GCP special interest groups (SIGs) have collaborated to create the basic documentation and collected feedback from all interested stakeholders. We have incorporated the vast majority of comments in the current version and have published a white paper discussing all topics where the comments were not assimilated. We will maintain the model by regularly opening the documents to comments and publishing updates. We will periodically hold a public forum for discussion and offer advise to interested parties, whether pharmaceutical sponsors or vendors.
Steve Scribner, BSEE The Scribner Group (USA)