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.

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

Supplier management

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

Examples of functionality:

  • Versioning
  • Full traceability 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:

  • Possibility to relate documents and other file types during the process
  • Graphical illustrations for great overview of your change control processes
  • Create and distribute tasks related to implementing decisions

Contract management

With the Advantum contract management module, your organization can manage, organize and distribute contracts in a smooth and time-saving way. With functionality for automatic reminders and cross-references you will gain the ability to connect your organizations agreements to different types of documentation, customers, suppliers, services and products.

Example of Advantum Contract Mangement features:

  • Flexible contract management with control over the company's contract processes
  • Ensure the quality of the content through efficient template management
  • Control the availability for different users and user groups
  • Notifications and alarm functions for expiring contracts
  • Controlled distribution
  • Ability to link contracts to documents, customers, suppliers and products

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

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