By the industry, for the industry!

 DIA Pocket Logo HiRes        cropped-edms-pocket8000pix.jpg


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. 


And also:

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.

Dimitri Stamatiadis, PhD, MBA                           Steve Scribner, BSEE                                      MAIA Consulting (Switzerland)                        The Scribner Group (USA)

Advertisements

One thought on “By the industry, for the industry!

  1. Hi Steve, Hi Dimitri

    thanks for providing this excellent material. I recently used the Pocket EDMS in a customer assignment as a reference. It helped me to provide good quality consutling. Keep up the good work.

    Best Regards
    Sven

    Liked by 1 person

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s