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.
Although deviations belong to the everyday work in organizations, many companies does not have defined process management for their deviations. By obtaining system support for such unwanted scenarios, clear
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).
Example of features in the Advantum deviation management module:
- Predefined workflows control the management
- Notifications via email and/or logging into Advantum
- 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 tracking capabilities
- Electronic Signatures and Records make it possible to approve/sign deviations and measure directly within the system, in compliance with the regulations in place for GMP and FDA 21 CFR part 11
Since Advantum is fully configurable, it can easily be set to match each customer's processes, demands and needs.
Join a webinar and learn more
Our webinars are an excellent opportunity to get a first impression of the possibilities Advantum creates. We offer webinars in a variety of fields. But, if you cannot find a webinar that fits your needs, feel free to contact us for a custom viewing made just for you.
Our webinars are naturally free of charge!