Life Sciences 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

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

  • 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.

 

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 any document
  • 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, 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

 

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

 

Validation Starter Package

Our Validation Starter Package is a collection of documents and manuals needed to validate Advantum.

The collection includes:

  • User Requirement Specification & Traceability Matrix
  • Configuration Specification
  • Installation Qualification
  • Validation Plan
  • Test Plan
  • Test Cases
  • Deviation Log
  • Test Report
  • Validation Report

Note that a validation project also depends on the customer’s existing quality management system (QMS).