Document management the way it's meant to work

Dossier management pharma

The regulatory requirements for the documentation of a pharmaceutical drug have steadily increased due to constant progress and new findings. As a result of this, the amount of data and the complexity of the registration of documents also increase, which places even higher demands on the handling of the included documentation.

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).

Examples of functions 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 information based on different perspectives and search functions
  • Management of access rights via groups and roles
  • Audit trail
  • Prepared import for documents

Operation

Advantum can either be installed in your server environment, in the cloud, or you can let us take care of the operation of Advantum in a strictly controlled server environment (Advantum ASP-service). Get in touch and we'll help you find the best operating solution!

Book a demo

Download Product Sheet

Fill out this form and we'll send you a free product sheet by email. That way you can read or print out the product sheet any way you want.
I WANT THE PRODUCT SHEET

Advantum is thoroughly tested and evaluated by

Karo healthcare
Astra Zeneka Logo
Cobra Biologics Logo
NorthX Biologics Logo

Some of the features

With Advantum Dossier management pharma you get an efficient solution to meet quality and regulatory demands in your industry.

Structural management of documents

Advantum Dossier management pharma simplifies and streamlines the handling of documents in one structure. In Advantum Dossier Management pharma, this takes place in a CTD structure that keeps track of both sequences and variations.

Regulatory requirements for IT environments

Validated document management system for organizations with high requirements for information management in regulatory environments. Prepared to be validated according to international standards.

Microsoft Office integration

Advantum is a partner with Microsoft, which means that there is full integration with Outlook, Word, Excel and PowerPoint.
5 STRONG ARGUMENTS

The user-friendly and flexible choice for information management

Plug & play

We have developed Advantum into a system that is as close to Plug & play as possible. If you don't want to make any changes to our finished ones pre-configurations, it's just a matter of getting started immediately, quickly and easily!

Anywhere

Today, it is obvious to be able to work anywhere and at any time preferably. For that reason, the system is developed to work just as well on your mobile device as on your computer.

Truly flexible

With Advantum's extreme flexibility, you can take on the challenges of today staying prepared for future needs and requirements for technical and organisational changes.

Flexible Licenses

Advantum is a flexible system, as is our licensing model! We use flexible licensing and focus on the number of concurrent users in the system. By sharing licenses, Advantum becomes a cost-efficient choice for you.

Personal Advisor

Our customers appreciated our support the most. As our customer, you can always contact your own personal advisor for easy and efficient handling of all your questions and issues.

Konfigurera Anpassa dokumenthanteringssystem
Flexible Licenses

Should you configure or customize
the system?

One of the strengths Advantum has is extreme flexibility combined with it being a standard software product. This combination means you can have management that matches your needs and requirements without needing to develop a custom solution.
Configuration
Configuration means achieving the management you're looking for with the help of standard components. No new functionality needs to be developed, instead the components are so flexible they can be configured to look and function as you want. The system can be easily kept up-to-date by using our latest version with minimal consulting efforts.
Customization
Customization means creating a system unique to a customer with functions that need to be maintained and updated separately for each individual customer. The functionality is not tried or tested and the costly work of keeping customer-specific systems updated often leaves further development under-invested or left out altogether.

Why we advocate configuration
instead of customization

Through the years, we have learned that the needs of our customers are often very different from one another. We have addressed this by offering the same system to everyone. Does that sound strange? It’s easy! What we do is simply configure the system to look and function according to your needs and requirements. This means that all of our customers have the same system, but that they often look and function in entirely different ways.

Why is the difference between configuration and customization
so important?

When you adapt 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.