Business Cases

  • Regulatory services, documents and data management
  • Assistance for Dossier preparation, production, submission and maintenance
  • Product safety management

Monday 07 March 2011 Document management: installation of validated platform

How to define and launch a global EDMS, starting from the R&D’s EDMS.

CLIENT


A large pharmaceutical company.


CONTEXT


Document management within the company (EDMS) was managed on a decentralized manner and separate systems, and should be consolidated to cover all the business functions and reduce the unit costs of the applications.


OBJECTIVES

  • To allow access to the EDMS for all the management needs of a controlled documentation.
  • To reduce the costs of installing, maintaining and validating each EDMS application.
  • To create good practices that help to simplify document management processes.
    To ease the management of the versioning and minimize the workload connected with change management.
  • To maximize the capacity of software components for re-use, and to minimize specific developments through applications.

ORGANIZATION OF THE MISSION    


In the context of the R&D system migration, to introduce a sub-project for defining the platform, under the supervision of Quality Assurance.     Definition of software architecture, identification of software and functional components, and formalization of validation plan.


RESOURCES
 

One information system architect.

One validation consultant.

 

RESULTS


Since the platform was introduced, six applications have been installed in the following functional domains :

  • R&D (submission documents, Trial Master file (clinical), PSUR, non-submission documents, integration with publication tool)
  • Packaging and artwork management
  • Validation documentation
  • SOP
  • Contract management.

Introduction of the ITIL process for managing incidents, problems, change and system administration.

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