Deviation management software: Reliable and straightforward
Handle deviations more easily and remain operational with deviation management
Deviations are possible in many areas, from the storage temperature to the chemical composition of a product. You need to act quickly to correct processes and avoid major damage. Automated deviation management software makes this simple.
Record deviations reliably and process them according to a controlled process
Respond promptly and initiate further measures
Document interrelationships and measures verifiably
Reliable documentation with electronic signatures
Automated response to discrepancies with deviation management
Do you want to reliably process and document deviations with digital workflows? Then Deviation Control is perfect for you: Enter deviation reports digitally in the system and trigger further processing steps via workflow. Block, review, or initiate CAPAs: As you process all measured digitally, the entire process is electronically documented. A further advantage: Sign all steps in compliance with the regulations, if required.
Paper processes are managed completely digitally with deviation management software.
The workflow system automatically forwards the digital form to the next instance.
The included substitution provision in the software enables functional task routing.
Timeouts are recorded by reminder and escalation management in Deviation Control.
Activities can be completed and confirmed with electronic signatures.
Deviation management software:
... This - and much more - awaits you:
YAVEON relies on the QM solutions of our partner d.velop Life Sciences
Consulting expertise meets proven features: YAVEON and d.velop Life Sciences - the perfect combination. YAVEON has years of experience and expertise in the regulated environment and serves numerous clients in the pharmaceutical and medical technology industries. The d.velop Life Science modules are precisely aligned to the needs of customers from the regulated environment and provide a solid foundation. The combination of professional consulting and smooth-running products is unbeatable. Take a closer look.
These regulatory requirements are met with deviation control:
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YAVEON QM modules - partner solutions of d.velop life sciences
In our YAVEON QM modules factsheet, you will learn
Questions are there to be answered.
The most important FAQs around deviation management
Each process step can only be processed separately. The other process steps are visible at all times.
You can configure the designation of the process steps, field designations as well as value sets directly in the workflow administration.
The process flow meets the requirements of the GxP regulations and is created with QM experts - the process steps are therefore mandatory. However, a "Custom Panel" can be used to display more information and initiate actions for each process.
Yes, process steps can be forwarded to another person. The authorization is checked in each case.
Essential data is transferred to the attributes of a data set. This makes it possible to perform a search and create evaluations. The export is done as a PDF, Excel, or Word document.
Yes, time specifications can be entered for each process step.
A process step is completed with an electronic signature - a correction is generally not supported. However, users can redirect the process back to a previous step and reprocess it. Backtracked processes are recorded in the audit trail.
Once a measure has been entered, it can be saved as a template.
Attachments can be uploaded and linked in all process steps. These are stored in the DMS and can be viewed by all parties in Deviation Control.