Document management the way it's meant to work

Claim & Deviation with CAPA

Quality deviations, environmental deviations, complaints- and production claims and deviations are unwanted but real scenarios and challanges that companies and organizations face on a daily basis. Events and cases that deviate from normal processes and process flows must be managed and prevented. Advantum Claim and Deviation Management helps you to capture, manage, document and prevent deviations from being repeated. By tailoring a framework for just how your organization wants to handle these processes, quality, traceability and prevention are guaranteed to prevent unwanted discrepancies.

Want to learn more abot Advantum Claim and Deviation management? Book a demo and learn more about how Advatum can help your organization!
Why Advantum's handling of complaints and deviations?

Despite the fact that complaints and deviations are part of everyday life in organizations, it is common that there is a lack of defined handling for these in many companies. By procuring system support for such unwanted scenarios, clear frameworks and principles are established for how deviations are to be handled. Advantum offers the tools for better collaboration and communication between everyone involved, where users can share information with each other and delegate tasks and actions to the right person with the right skills.

frameworks and principles for managing deviations are established with Advantum. The Advantum Deviation Management module handles information as a result of a deviation such as error messages, alarms, emails, documents and cases. By collecting all of this information, Advantum Claim and Deviation Management offers the tools to handle and correct deviations in the best possible way, as well as a plan for how they can be prevented in the future. Advantum Deviation Management helps you handle deviations according to the rules of Good Manufacturing Policies (GMP), Food and Drug Administration Part 21 (FDA 21) and Code of Federal Regulations Part 11 (CFR Part 11).

Functionality includes:
  • CAPA - Corrective Actions och Preventive Actions
  • Predefined workflows that control the deviation management
  • Notifications via e-mail to affected persons and departments
  • Escalating alarms based on pre-set time frames
  • Status and permission controls
  • Version management
  • Graphical presentations of the process and status
  • Audit trail for secure traceability
  • Electronic Signatures and Records make it possible to approve/sign deviations and measures directly in the system

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 (Advantum ASP-service). Get in touch and we'll help you find the best operating solution!

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Advantum is thoroughly tested and evaluated by

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Some of the features

With Advantum, you can detect and prevent complaints, production deviations, environmental deviations and quality deviations.

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 and 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.
5 STRONG ARGUMENTS

The user-friendly and flexible choice for information management

Plug & Play

We have developed Advantum into a system that is as close to Plug & Play as possible. If you don't want to make any changes to our finished ones pre-configurations, it's just a matter of getting started immediately, quickly and easily!

Anywhere

Being able to work from anywhere you want is entirely natural today. That's why Advantum is developed to function as well on your smartphone and tablet as on your computer.

Truly flexible

With Advantum's extreme flexibility, you can take on the challenges of today staying prepared for future needs and requirements for technical and organisational changes.

Flexible Licenses

Advantum is a flexible system, as is our licensing model! We use flexible licensing and focus on the number of concurrent users in the system. By sharing licenses, Advantum becomes a cost-efficient choice for you.

Personal Advisor

Our customers appreciated our support the most. As our customer, you can always contact your own personal advisor for easy and efficient handling of all your questions and issues.

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Flexible Licenses

Should you configure or customize
the document management system?

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.

Why we advocate 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.

Why is the difference between configuration and customization
so important?

When you adapt 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.