Advantum Dossier management is an efficient solution for creating, maintaining and archiving documentation in a CTD (Common Technical Document) structure.
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.
With Advantum Dossier management, you get the benefits of a powerful document management system combined with the management of the documentation in a CTD structure with its sequences and variations. Advantum Dossier management of course also automatically controls the "Current file" and which documents that are approved by the authorities. From Advantum Dossier management, structured information can be exported as a basis for an eCTD (electronic Common Technical Document).
With Advantum Dossier management MedTech you get an efficient solution to meet quality and regulatory demands in your industry.
For those of you who work in the field of medical technology, the challenges are becoming increasingly demanding, which places higher and higher demands on your quality system.
With Advantum Dossier Management MedTech, you get the benefits of powerful system support that helps you create, maintain and archive documentation throughout the entire process from idea and development phase to finished product.
The use of Advantum Dossier Management MedTech eliminates inefficient and time-consuming processes while saving the documentation in a standardized structure.
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When you customize a system, you create something unique for a customer which then needs to be maintained in an equally unique way. A configurable standard system can be maintained through common maintenance and is therefore much more cost efficient.