Regulatory services, documents and data management

Monday 07 March 2011 Preparation of long term archiving of documents


Having to cope with the increasing size of their archives and the obligation of long-term storage of certain sensitive documents, pharmaceutical companies are becoming interested in the electronic archiving of documents and the storage of their paper documents under the best possible conditions..


CLIENT


A large International pharma central group, based in France.


CONTEXT


Wishing to anticipate an imminent relocation, a major laboratory has taken the decision to speed up the long-term archiving of several dozen files (sponsorship files, marketing authorisations) and externalize the storage of the documents with a third-party archiving company.


The documentation department relies on the experience of ProductLife to prepare the archive boxes and their detailed indexing into the laboratory information system (EDM).


OBJECTIVES


  • Reviewing each study in order to organise the documents according to the existing classification that can change depending on our recommendations.
  • Filling the documentary database in order to reference the content of each archive box and each container prepared.
  • Preparing the archive containers to be sent to the third-party archivist.

 

ORGANIZATION OF THE MISSION
 

The mission is carried out in different steps:

  • Evaluation of the work to be conducted through a phase of tests lasting a few weeks:

This period allows for a detailed analysis of the project, evaluation of the resources and their typology, the definition of the organisation as well as the processes to be set up, the overall budget for the task and its phasing, and the setting up of reporting and invoicing tools.

The diversity of documents and processes to be applied  made the analysis of the overall volumes extremely difficult.

The documents did not benefit from the same storage conditions, identification, physical preparation or removal of duplicates, making it impossible to apply “average” measures.

  • Implementation of a so-called “pilot” period with a small team:

This phase validates the planned organisation by treating new studies at an industrial level. It also validates the method ofinvoicing the work units (6 units were defined), and allows the laboratory to plan, with its internal departments, the joint work to be done with the ProductLife teams.

  • Implementation of the project with the responsibility ofProductLife teams to respect the deadlines required by the client.

The management control and procurement departments effectively monitor the expenses incurred and still to be incurred.

 

RESOURCES 


  • 1 experienced research assistant for the test and analysis phase.
  • 3 additional experienced research assistants for several months in the pilot phase, within small production workshops.
  • Several additional experienced research assistants and archivists in the “industrial” phase to manage all the stocks in order to guarantee the continuity of the production, even during the summer period. 
  • 1 project manager to guarantee the good progress of the task on the client site in terms of human, qualitative, quantitative and financial requirements.

RESULTS


Since the introduction of the team, the quality processes have been revised and validated, a refined indexing methodology for the EDM tool has been introduced, and the preparation of the archives of each department is progressing well, thanks to a good coordination between ProductLife and the client.

The progress of the project is fully consistent with the forecasts, and meets the client’s requirements.









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