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.

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.

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. Get in touch and we'll help you find the best operating solution!

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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 over periodic insight of the document

Full tracking ability and audit trail

Summaries 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 and 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, current, and completed cases

List of involved products, customers, and suppliers

Electronic signatures

Alarms and reminders

Clear divisions of responsibility and evaluative feedback

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 the company and individual levels

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.

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

Advantum change control is a component suitable for organizations and companies that want to ensure and improve the quality of internal processes.

Functionality includes:

Version management

Audit trail

Good overview on change requests and change orders

Control and tracability on changes that are being made and have been done

Possibility to manage changes in documents, clients, suppliers, products etc.

Contract Management

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

Functionality includes:

Version management

Audit trail

Template management

In-system and email notifications

Follow up and extention

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 and similar

5 STRONG ARGUMENTS

The user-friendly and flexible choice for information management

Plug & Play

Anywhere

Truly flexible

Flexible Licenses

Personal Advisor

Konfigurera Anpassa dokumenthanteringssystem

Should you configure or customize
the system for document management?

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.

That's why we recommend 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.

But why is the difference between configuration and customization
so important?

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.

Industry solutions

Components

Customer-specific

Services

Knowledge Center

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.

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.