Document management the way it's meant to work

Life science suite

Advantum Life science suite is an industry solution that is aimed towards companies and organizations which operates in the Life science sector. The industry solution is an electronic quality system that is produced and developed to be able to meet and be validated according to strict regulatory requirements and international quality standards.

Life Science dokumenthantering

Advantum Life science suite includes several products, Advantum platform, several pre-configurations that are intended to work as an eQMS (electronic Quality Management System). What is included in this industry solution has been developed together with some of Sweden’s leading players in this sector and based on the long experience we have in developing solutions for companies and organizations in this sector.

This industry solution is today used by both Swedish and foreign companies and organizations who must safely and efficiently manage their contracts, documents, SOP:s, product dossiers, suppliers, claims, deviations, training materials and changes to meet the regulatory requirements that exist.

Advantum Life science suite and its included products have undergone several validation processes to ensure intended use but also to ensure that it meets the requirements that are set in for example ISO (International Organization for Standardization), GMP (Good Manufacturing Practice) and FDA (Food and Drug Administration) which is proof that this industry solution meets the strict quality requirements that are set.

It is possible to choose to procure the entire industry solution i.e. everything included or select the pre-configurations and documentation that there is a need of. Thanks to the fact that Advantum is very flexible and configurable it also opens the possibility to quick and easy make any changes that are needed but still be within the scope of a standard product.

Advantum Life science suite includes the following pre-configurations:

  • Contract
  • Document management
  • Dossier management MedTech
  • Dossier management pharma
  • Supplier management
  • Claim & deviation with CAPA
  • Training management
  • Change control

Advantum Life science suite includes the following documentation:

  • Validation starter package

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!

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Advantum is thoroughly tested and evaluated by

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Advantum Life science suite innefattar följande

Document management

With Advantum Document management, companies and organisations can manage all documentation in a unified and structured way.

Functionality includes:
Create and mange projects
Create and manage documents
Template management
Version management
Electronic signature
Create and manage and sign with role
Standardized processes
Compilation of who has read and understood a document
Controlled printing
Reminders for periodic review of documents
Find information based on different perspectives and search functions
Management of access rights via groups and roles
Audit trail
Prepared import for documents
This functionality complies requirements from FDA (Title 21 CFR part 11) and the EU (Annex 11) among others.

Claim & Deviation with CAPA

Automated processes to manage a variety of claims forms, quality deviations, environmental deviations, product deviations, proposals for improvements and incident reporting. Corrective Actions and Preventive Actions (CAPA) can also be added to the above types of cases.

Functionality includes:
Full tracking ability and audit trail
Overview of new, ongoing and closed cases
List of involved products, customers, and suppliers
Electronic signatures
Alarms and reminders
Clear division of responsibilities and reporting back
Graph illustration
Link documents and images
With the Advantum audit trail and electronic signature capability, this enables complying with various requirements from authorities and institutions including both the EU (Annex 11) and FDA (Title 21 CFR part 11).

Training management

All functionality required for electronically managing training. An easy and efficient way to manage and record staff competencies regarding educational and in-service training, electronic signatures, job descriptions, education, courses and course material, training, diplomas, CVs and more for individuals.

Functionality includes:
Training plans at corporate and individual level
Manage courses with corresponding course material and documents
Training records; Read & Understood confirmations, completed courses and diplomas awarded

Validation starter package

Advantum Validation Starter Package is a validation framework created to simplify and speed up the implementation and validation of Advantum's Life Science Suite.

The Advantum Validation Starter Package consists of the following:
User Requirement Specification
System Requirement Specification
Configuration Specification
Installation Qualification Protocol & Report
Operational Qualification Protocol & Report
Performance Qualification Protocol & Report
Deviation Log
Deviation Form
Requirement Traceability Matrix
Configuration Items List
Risk Assessment
Validation Plan
Validation Report

Supplier management

Contains the functionality needed to manage, follow up and risk assess suppliers.

Functionality includes:
Version management
Full tracking ability and audit trail
Risk assessment of suppliers
Evaluation, approval and follow-up of suppliers
Create relationships between supplier, documentation, contact persons, products etc

Change control

All the functionality needed to better control which changes are made and that they are implemented.

Functionality includes:
Version management
Audit trail
Good overview of change requests and change orders
Control and traceability of changes that are ongoing and have been made
Possibility to manage changes in documents, clients, suppliers, products etc.

Contract

With the Advantum Agreement module, your organization can manage, organize and distribute agreements and contracts in a smooth and time-saving way.

Functionality includes:
Version management
Audit trail
Template management
In-system and email notifications
Follow-up and extension
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

Being able to work from anywhere you want is entirely natural today. That's why Advantum is developed to function as well on your smartphone and tablet 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 document management 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 without any specific consulting.
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.