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Business Cases

GED: Optimisation and introduction within an eCTD perspective Thursday 19 February 2009

To preserve the eCTD resources and help GED to evolve in position.

Client:

A major pharmaceutical laboratory, International Regulatory Affairs Department and R&D Department.

 

Context:

The GED application used by the posts producing documents for the regulatory files is not adapted for preparation of submissions in eCTD format. It needs to develop while protecting the documentary resources already produced.

 

Objectives:

To compile documents intended for “ready for use” submission via:

• The use of new templates, in phase with the granularity of the eCTD and format and navigability requirements
• The addition of attributes necessary at document level for identifying files within the eCTD submission.

To re-use the documents in several different submissions, and to facilitate the analysis of impact in the event of change, thanks to:

• Rigorous management of the life cycle and versioning of documents
  

• Decoupling between the Posts and Submissions GED zones, combined with the management of links between documents and submissions in these two zones.

During the framing phase, an additional target became apparent:

• To facilitate constitution of the file during the process, by combining the running of development projects and the definition and monitoring of documentary deliverables.

 

 Organisation of the task:

• Analysis of current practices and the GED in place (framing phase).

• Definition of changes to be introduced and their level of priority (schedule of charges and project plan).

• Accompaniment during change in particular through training, pilot introduction, organised feedback of experience and finalisation of processes.

Resources applied:

• 1 task manager, 1 senior consultant, 1 experienced consultant.

• The full task lasted 12 months with a load of 1.5 full-time equivalents over that period.

 

Results:

The new GED system is operational and the laboratory has been able to integrate the eCTD into routine without interruption, together with the new file consultation processes, as things developed.