Dossier preparation, production, submission and maintenance

Friday 04 March 2011 EDMS : Optimization and introduction within an eCTD perspective Client


To preserve the eCTD legacy and support evolution of the actual EDMS.

 

CLIENT

 

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

 

CONTEXT

 

The EDMS application used by the posts producing documents for the regulatory files is not properly fitting to the preparation of submissions in eCTD format. It should evolve while protecting the documentation already produced.

 

OBJECTIVES

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

  •      The use of new templates, in accordance with eCTD’s granularity, format and navigability requirements.
  •      The addition of attributes necessary for identifying files within the eCTD submission.

2. 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 the Posts and Submissions zones in the EDMS, combined with the management of links between documents and submissions in these two zones.

3. During the framing phase, an additional target appeared :

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

ORGANIZATION OF THE MISSION

  • Analysis of current practices in the actual EDMS (framing phase).
  • Definition of changes to be introduced and their levels of priority.
  • Assistance and support during the change period, particularly through trainings, pilot introduction, organized feedback of experience and finalization of processes.

RESOURCES

  • 1 project manager, 1 senior consultant, 1 experienced consultant.
  • The full lasted 12 months with a workload of 1.5 full-time equivalents over that period of mission time.

RESULTS

The new EDMS is operational and the laboratory has been able to integrate the eCTD in routine without interruption, together with the new file consultation processes.

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