Electronic Document Management

Electronic Document Management System (EDMS)

Samarind RMS has a built-in document management system that can be used for the creation, storage and maintenance of all your regulatory documents, whether they are related to your pharmaceutical or device products or to the organisations and people you deal with. SmPCs, company core data sheets (CCDSs), eCTD documents, certificates, GMP reports, safety agreements and Med Info correspondence are all handled with ease.

  • Templates with placeholders improve the speed at which correctly-formatted documents can be created. When a new document is created, the system takes the relevant data out of the database and inserts it into the document at the designated places. This process follows the Emerging Dossier Concept, which ensures data accuracy and support information consistency throughout.
  • A full set of EU eCTD templates is also available, allowing authors to concentrate on content rather than formatting.
  • Version control and ‘check out, check in’ facilities keep documents under control.
  • Document ‘sharing’ avoids duplication and provides visibility of all data affected by a change. For example, a safety agreement can be linked to the organisation and the marketing authorisations it relates to.
  • By default, all documents are stored securely inside Samarind RMS database; because they are not stored on a network shared drive they can only be viewed and edited by authorised personnel and they cannot be inadvertently moved or deleted.

Alternatively, the system can be configured so that it links to other document management systems like SharePoint™ or Documentum™.

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