Product Safety Management

Friday 11 March 2011 eCTD : into an EDMS


Introducing eCTD format helped the global document management evolution.

CLIENT


A major pharmaceutical Company, Department of International Regulatory Affairs.


CONTEXT


Introduction the eCTD format into the presentation of marketing authorization files and variations together with the deployment of a new EDMS.


OBJECTIVES

  • Improving consultation and accessibility of information in the Client’s products.
  • Enabling future submissions to be made in eCTD format.
  • In a near future, introducing a real document life-cycle management.

 

ORGANIZATION OF THE MISSION

  • To identify the existing marketing authorization files for 7 products, in the current file system, to format them in eCTD, and then transfer to the whole into the new EDMS.
  • To carry out the checks and corrections necessary for the integrity of the content finally stored in the EDMS.

RESOURCES    


  • 1 scientific post-graduate, skilled in foreign languages on an “in-sourcing” basis during 6 months    
  • 1 regulatory expert for tasks monitoring and guaranteeing the quality of the deliverable from a business viewpoint.

RESULTS

A customized support for the Client in its evolution towards e-CTD.


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