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

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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.

The 10 biggest benefits of deviation management software

Deviation management software:

... This - and much more - awaits you:

  • Use the automatic PDF creation and form filing in your eDMS reliably after each step.
  • Automatically classify discrepancies based on the metadata you entered into the form.
  • Master data is referenced directly from your ERP system.
  • Add documents, for example, digital photos, to Deviation Control.
  • Initiate individual tasks to continue work on your processes.
  • Receive escalation notifications directly in the system or via email.
  • Use the option to designate a substitute.

with partnerships

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.

Logo d.velop Life Sciences

These regulatory requirements are met with deviation control:

  • ISO 9001:2015, Chapter 8
  • ISO 13485:2016, Chapter 8
  • EU-GMP Guideline Part 1, Chapter 8
Fulfilled regulations of deviation management software

Curious to learn more?

YAVEON QM modules - partner solutions of d.velop life sciences

In our YAVEON QM modules factsheet, you will learn

  • how to organize controlled documents,
  • how to respond if something goes wrong,
  • how to plan and record qualifications of your employees
  • how to integrate modules and systems,
  • how to train your employees,
  • how to create a CAPA and access it repeatedly,
  • and much more.
Preview Factsheet Digital Quality Management

Questions are there to be answered.

The most important FAQs around deviation management

Are the contents of the process steps viewable in Deviation Control?

Each process step can only be processed separately. The other process steps are visible at all times.

Can I change the designations used in the Deviation Control?

You can configure the designation of the process steps, field designations as well as value sets directly in the workflow administration.

Can I change the predefined steps in the Deviation Control?

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.

Is it possible to delegate tasks in Deviation Control?

Yes, process steps can be forwarded to another person. The authorization is checked in each case.

Can Deviation Control be evaluated?

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.

Are there time constraints to process steps in Deviation Control?

Yes, time specifications can be entered for each process step.

Is it possible to correct process steps in Deviation Control retrospectively?

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.

Are templates available for measures in Deviation Control?

Once a measure has been entered, it can be saved as a template. 

Can I store attachments in Deviation Control?

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.

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