Quality Management System (eQMS) for Life Sciences

Advantum Life science suite is an eQMS / document management system (DMS) aimed at companies and organizations operating in the Life Science sector.

Specially adapted for Life Science, Biotech, Medtech and Pharma

Advantum Life Science Suite is an electronic quality system (eQMS software) designed and developed to meet, and be validated according to, strict regulatory requirements and international quality standards.

Meeting regulatory requirements is one of the biggest challenges for companies in life science, biotech, medtech and pharma. With Advantum you get a complete QMS software solution that combines document management, case management and regulatory compliance – built to meet MDR, IVDR, GxP, GCP, GLP and international standards like ISO 13485 and ISO 14971. Our software can be configured for your specific ISO-standard requirements.

Developed in close consultation with leading companies

Advantum Life science suite is a complete package containing the Advantum platform and most of the pre-configurations that together form a complete eQMS software solution. Every aspect included in this industry solution has been developed together with some of Sweden's leading companies in this sector and based on the long experience we have in developing solutions for companies and organizations within Life Science.

Who is it for?

Today, this industry solution is used by both Swedish and foreign companies and organizations that need to securely manage their contracts, documents, SOPs, product dossiers, suppliers, claims, deviations, education material and changes to meet existing regulatory requirements.

Software that meets stringent requirements

It is possible to combine this industry solution with other pre-configurations if there is a need to manage other types of information than what is included in this industry solution. Thanks to Advantum being very flexible and configurable, it also opens up the possibility to quickly and easily make any changes that are needed but still be within the framework of a standard product.

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.

Why companies in Life Sciences need
Quality Management software

Ensures regulatory compliance in a highly regulated industry

Creates order and traceability in all processes

Reduces risks and increases quality

Streamlines work with documents, deviations, CAPA and audit trail

Advantum Life Science Suite is

Document Management software

Management of all quality-related documents with version control, access management and electronic signatures..

Electronic quality system

Supports CAPA, change control, deviation management and risk management – in accordance with GxP.

CTD structured dossier management

Build dossiers in accordance with CTD and export them to eCTD. With full traceability for regulatory submissions.

Compliance and ISO standards

Our software is designed to facilitate compliance with ISO 13485, ISO 14971, MDR and IVDR. The system is customizable for your specific regulatory requirements.

To whom is Advantum DMS/eQMS suitable for?

Ciotech companies that need a validatable quality system
Medtech producers which must comply with MDR and IVDR
Pharma and CROs that work in accordance with GCP and GLP
Organisations that need a flexible software solution for regulatory environments

Life Science and Pharma companies that use Advantum

Frontgrade Gaisler chooses quality-assured DMS

Frontgrade Gaisler, a world leader in embedded computer systems for the aerospace industry, chose Advantum to quality assure its document management. They needed a flexible system that could grow with the business and handle critical information securely.

Moberg Pharma – dossier management within pharma

Moberg Pharma has chosen Advantum Dossier Management Pharma to streamline and quality-assert the entire process from idea to finished product. The system ensures compliance with the industry's strict requirements and provides full traceability.

SenzaGen – document management as a service

SenzaGen uses Advantum as a Service (SaaS) to manage their documentation in a secure, web-based environment with data stored in Sweden. With Advantum, they avoid investing in hardware and gain access to powerful, modern system support.

Niconovum (British American Tobacco) – dossier management

Niconovum has chosen the Advantum Dossier Management Pharma service solution to meet regulatory requirements and streamline document management. The company develops nicotine products under the Zonnic® brand.

BioArctic - new Life Science case

BioArctic, a research-intensive biopharmaceutical company in CNS diseases such as Alzheimer's and Parkinson's, has chosen Advantum as their document and quality management system software. With Advantum, they get a validatable software solution specifically developed for Life Science.

Other well-known customers

In addition to these, AstraZeneca, Orexo, NorthX Biologics and Alligator Bioscience have also chosen Advantum for their DMS and eQMS software needs.

Advantum Life science suite includes

Contract management

With Advantum contract management, you can manage all your contracts with customers, suppliers, contractors, partner companies, employees, etc. from the first draft to the current version or to signed copies.

Document management

Efficient document management is an important process for all organisations. Advantum creates a controlled and efficient environment while the flexible permissions system controls access and licensing.

Dossier management pharma

With Advantum Dossier Management Pharma you get the benefits of a powerful document management system combined with handling the documentation in a standardized structure.

Dossier management MedTech

With Advantum Dossier Management Pharma you get the benefits of a powerful document management system combined with handling the documentation in a standardized structure.

Supplier Management

In this tool everything is handled from traditional contact information to more complex evaluation processes and risk assessment of suppliers.

Claim & deviation management

Deviation management in Advantum enables efficient management of many types of deviations and cases, such as quality deviations, environmental deviations, claims, production deviations, incident reporting and change management proposals.

Training management

Advantum Training management is a solution to efficiently create and maintain documentation relating to an employee's education/training. The system makes it easy to report the staff's competence regarding CV, diploma, job description, courses, course material and training plan from a personal perspective. All this is stored on the person's "Training records".

Change Control

The Change control component lets your company work with change processes in a structured way. With functions like creating change requests, evalution, implementation decisons and creating of tasks for the implementation you get a holistic approach for your change control processes.

Validation starter package

Advantum Validation starter package is a standard package that contains a set of documents required to perform a validation of Advantum pre-configurations. Since many of the documents are written, it is possible to quickly get started and begin the work with the validation.

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!

FAQ about QMS software in Life Sciences

Which biotech companies should have a quality management system?

Anyone who develops, produces or distributes life science products is subject to quality system requirements. An eQMS ensures that processes comply with regulations and standards from the start.

What should a quality management system for Life Sciences feature?

An eQMS should include document management, risk management, CAPA, change control, deviation management and audit trail – always with full traceability.

What regulations and ISO standards should eQMS software meet?

The most important are MDR, IVDR, GxP, GCP, GLP as well as ISO 13485 and ISO 14971. Advantum is designed to meet your regulatory requirements and standards.

Is an eQMS needed if you are just rebranding or repackaging medtech products?

Yes, relabeling and repackaging are also covered by the MDR and require documented quality assurance.

How do you implement QMS software in Life Science?

With Advantum, implementation can be done in stages. We offer pre-configurations with the modules that suit your way of working to get you started quickly, which can then be adapted to your organization's needs.

Do you want to reduce administration and get better order in documents and drawings in product development?

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