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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