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Advantum Life Science Suite

Advantum Life Science Suite is a niche Data Management System for companies and organizations active in Life Science. The system has been developed to meet and to be validated according to strict regulatory requirements and international quality standards.

Life Science dokumenthantering
Together with some of Sweden's leading players in Life Science, Advantum Life Science Suite has evolved into a reliable and quality assured DMS that ensures that information, product development, research and studies are managed qualitatively and accurately.

Advantum Life Sciences Suite is a pre-packaged Quality Management System (QMS) based on best practice and designed especially for small and mid-sized companies looking for a more cost-efficient comprehensive solution for their information management.

The solution is used by companies and organisations in Life Sciences for secure and efficient management of their documents and processes to comply with regulatory requirements. The Advantum Life Sciences Suite pre-configured solution gives you a comprehensive solution for an efficient electronic quality system.

The Advantum Life Sciences Suite includes:

  • Standard Operating Procedures (SOP)
  • Claim and Deviation with CAPA
  • Training Management
  • Document Management
  • Supplier Management
  • Change Control
  • Contract Management
  • Validation Starter Package

The Advantum Life Sciences Suite solution combines Advantum's unique flexibility, full configurability, with our years of experience in information management within Life Sciences. Our Advantum solutions are known for being easy to implement, use and validate.

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!

READ MORE ABOUT ADVANTUM ASP-SERVICE

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Advantum is thoroughly tested and evaluated by

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Karo healthcare
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Alligator Bioscience Logo
NorthX Biologics Logo

Network partners

The Advantum Life Sciences Suite includes

Standard Operating Procedures (SOP)

All functionality needed for managing policy documents electronically across its life cycle.

Functionality includes:
Version management
Electronic signatures
Template management
Control of periodic review of documents
Full tracking ability and audit trail
Compilation of who has read and understood
Ability to create relations to guidelines, instructions and similar
Controlled printing
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.

Agreement

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

Document Management

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

Functionality includes:
Version management
Template management
Audit trail
Create links between documents and other documents, cases, images, products etc.
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.