Claim & deviation management

A structured and quality-assured handling of deviations and claims is crucial for companies that want to work proactively with quality, risk and regulatory compliance. When documentation, follow-up and responsibility lack clear processes, the risk of recurring errors, insufficient measures and information gaps increases. Advantum Claim & Deviation Management provides a stable framework for capturing, investigating and addressing events that deviate from normal processes – while preserving lessons learned for the future.

Deviation management with full traceability

In Advantum, it is easy for employees to report a deviation or claim immediately when it occurs. The user can classify the event, relate documents, enter root cause and describe actions. The system then provides a clear overview of responsibility, status, priority and timeline, enabling faster and more accurate decisions.

All steps are automatically logged, and the built-in audit trail ensures full traceability – an important foundation for quality systems in areas such as Life Science, manufacturing, logistics and industry.

Developed in close consultation with leading companies

Advantum Claim & Deviation management is one of our pre-configurations within the Advantum platform, developed for businesses that need a structured and efficient handling of deviations and claims. In addition to this, Advantum also offers tailored industry solutions developed in collaboration with some of Sweden's leading companies.

CAPA – Corrective Action & Preventive Action

An effective deviation process requires not only that problems are fixed – but that they are prevented. That is why Advantum supports the entire CAPA process: from investigation and analysis to implemented measures and verified effect. Corrective and preventive measures can be assigned to responsible persons, followed up and approved in the system, which provides a quality-assured and reproducible method for continuous improvement.

Document management for suppliers, products and internal processes

The system makes it possible to link claims and deviations to products, customer cases, suppliers or internal processes. Documentation, drawings, logs and reports can be related directly to the event, creating a complete and comprehensive picture of causes and consequences.

This provides quick access to relevant information and facilitates both internal follow-up and reporting to authorities when necessary.

Effective follow-up and reporting

Advantum offers powerful filters to sort deviations by type, classification, date, product, customer, supplier and other key values. These can be easily exported as reporting data – for example, during management reviews, internal audits or external reviews.

Reminders ensure that nothing is forgotten and that follow-up is done on time, which creates high quality and reduces the risk of recurring problems.

Some of the features

Since Advantum is fully configurable, it can easily be set to match each customer's processes, demands and needs.

Relations and cross references

Advantum Deviation Management enables you to reliably relate all information relating to a specific deviation to get an overall picture of the whole deviation, its status, and what actions it awaits.

Follow-up and process optimization

Advantum gathers, logs and connects all information created in within a claim or deviation. Advantum's quality assured framework creates the opportunity for optimization and follow-up that continuously improves the work with deviation management.

Quality Assurance & Validation

Advantum Deviation Management ensures that deviations are handled in a quality assured way, enabling companies to be validated according to international standards and principles such as GMP, FDA and ISO.

Features in Advantum Claim & Deviation Management

Create and manage claims, deviations and CAPA
Classify and analyze deviations with root cause and actions
Relate documentation and track the entire information flow
Templates, standardized processes and electronic signatures
Version management and audit trail
Reminders and automated notifications
Role-based access for secure management
Efficient search and filtering
Import of documents and history

FAQ about deviation management & CAPA

What does deviation management mean?

It is the process of identifying, documenting, investigating and addressing events that deviate from regular procedures or quality requirements.

What is CAPA?

CAPA stands for Corrective Action and Preventive Action – measures to correct causes and prevent the problem from recurring.

Can Advantum handle customer claims?

Yes, claims can be registered, followed up and linked to documents, products and suppliers.

Is it possible to follow the status of a deviation in real time?

Yes, the system shows the current status, responsible person, timeline and any ongoing CAPA activities.

Is Advantum suitable for businesses with regulatory requirements?

Absolutely. The system supports audit trails, electronic signatures and standardized processes that meet GMP, ISO and FDA requirements.

Companies that choose 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.

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!

Do you want to simplify the handling of claims and deviations – and ensure that no actions fall through the cracks?

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Industry solutions

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Documentation

Pre-configurations

Solutions

References