Dossier management pharma
The regulatory requirements for the documentation of medicines have increased steadily due to constant progress and new results. As a result, it also increases the amount of data and the complexity of the registration dossiers, which places greater demands on the handling of the included documentation.
The use of Advantum Dossier management eliminates inefficient and time-consuming processes for handling the documents that you need for your regulatory submissions.
Advantum Dossier Management Pharma is an efficient solution for creating, maintaining and archiving documentation in a CTD (Common Technical Document) structure that is automatically generated for products.
Advantum Dossier management pharma helps create, maintain and archive documentation for products in a CTD structure where they are handled with variations and sequences as well to easily follow what have been sent to authorities and also store the correspondence. The system of course automatically keep track on the "Current file", i.e. which documents are approved by authorities. The structured information and files can easily be exported as a basis for an eCTD (electronic Common Technical Document).
Some of the features in Advantum Dossier Management Pharma:
- Create and manage products
- Manage CTD structure, variations and sequences for different countries
- Structure documentation according to CTD structure
- Create and manage documents
- Template management
- Version management
- Electronic signature
- Create and manage and sign with role
- Standardized processes
- Find documents through different perspectives and search functions
- Management of access rights via groups and roles
- Audit trail
- Prepared import for documents
