DOCmanager
The perfect add on to eCTDmanager™
The Challenge
The marketing of pharmaceutical products in multiple countries and regions can become extremely complex. While most of the information (80-90% of core information) applies to all countries or regions, some information applies only to specific countries or regions. For lifecycle operations, where specific documents are replaced, added or deleted, changes often apply to multiple countries.
Active pharmaceutical ingredient manufacturers face a similar challenge preparing different submissions for different authorities in different countries. Selling just one active substance to 5 customers that operate in 5 countries means managing 25 dossiers in parallel. Dossiers can evolve into different versions for internal use and customer use; handling open and restricted parts in dossiers can add even more complexity.
The Solution
DOCmanager addresses the reuse of dossiers across a broad spectrum of possible scenarios. It extends the rich functionality of eCTDmanager with a "parent/child" concept. By maintaining the parent, child dossiers can be automatically updated solving several common dossier management challenges. DOCmanager fully supports this fundamentally time consuming process by focusing on efficiency and quality control. Changes in the parent dossier can be controlled for quality and inherited by the children without the need for revalidation.
DOCmanager supports labelling in different regions and countries. The European MRP and DCP procedures are fully supported, enabling the user to update individual country submissions or to create group updates.
In addition to documents, inter- and intra-document hyperlinks as well as print publishing templates maintained on the parent dossier can be passed on to child dossiers. This capability allows you to manage changes on any level of the ”dossier family” by inserting the change just once and then passing the change on to all related dossiers.
DOCmanager can also be combined with document queries to search for documents with specific metadata and to place these documents automatically into the eCTD structure within eCTDmanager. These benefits make DOCmanager the perfect addition to EXTEDO's eCTDmanager!
Functional Overview
- Allows creation of parent dossiers using existing dossiers (save as template).
- Provides algorithm that compares parent documents with the child dossier documents. This algorithm ensures that all changes are introduced into the corresponding child, including eCTD lifecycle, hyperlinks, M1 envelope and STF information.
- Supports generation as initial submission of a newly created dossier, creation of a new submission within a dossier, and merging changes into existing submissions.
- Generation of changes to a single parent submission or a cumulated generation considering previous parent submissions.
- All generations can be simulated in order to evaluate changes of a prior generation.
- All generations are displayed in a separate view allowing easy navigation between parent and children.
- Conflicts in generation are maintained persistently in a task list and can be processed one after another.
- A generation protocol is created and stored for later access.
- Provides distinct user rights and permissions (not inherited from eCTDmanager), allowing fine-tuned control of security.
- Uses the Document Query concept and document placeholders that will be resolved upon submission generation.
- The documents can be automatically detected from the EDMS, database or Excel ®.
- Automated document selection based on a document’s structure and characteristics brings the parent concept to the next level.
- Characteristics can be configured to be compliant with the EDM Reference Model or your internal document structure.
- Product data like substance information and the source of manufacture can be retrieved and populated automatically.
