Change control software: Handle changes reliably

Faster results with digital change control software

Change control - a complex task. Undertaking change management in a company is like managing many simultaneous projects. Planning changes, assessing risks, and implementing measures involves a significant workload. Change Control software makes it easier.

Reduces time required thanks to workflows

Fewer errors thanks to automated processes

Keeps all activities, participants, and appointments together

Automates change control processes


Managing changes with change control software

Change Control: This is a typical process in quality management in which many people are involved. It also results in a lot of information that needs to be processed and documented. Processes that are handled manually quickly become confusing and take up a lot of time. Change control software can simplify all of this with digital workflows.

Digital management of processes that were previously handled on paper.

From acquisition to completion: All steps are digital throughout.

Automatic forwarding of the digital form to the next instance.

Information and documents are processed directly and easily in the module.

Reminder and escalation management in case of timeouts.

Substitution provision included in the solution for straightforward task routing.

The solution is an optimal addition to the Deviation Control module.

Completion of activities and their documentation with electronic signature.

Change control software: The 10 biggest benefits

Change control software

This - and much more - awaits you:

  • Classify your Change Control processes by type.
  • Evaluate your changes in the dynamic CC form according to approval, registration, or GMP relevance and in a consistent manner.
  • Use distribution lists to plan, edit, and approve actions.
  • Benefit from optional feedback during the process.
  • Log activities in the audit trail.
  • Send tasks in parallel and sequentially.
  • Create PDFs automatically and file the forms in eDMS.
  • Reference master data from your ERP system.

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

Important regulatory requirements that are met with change control software:

  • ISO 9001:2015, Chapter 8.5.6
  • ISO 13485:2016, Chapter 4
  • EU-GMP Guideline Part 2, Chapter 13
Fulfilled regulations of change 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 change control software

Can I store attachments in Change Control?

You can upload and link the required attachments in the process steps. These are stored in the DMS and can be viewed in Change Control.

Is it possible to change the designations used in Change Control?

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

Can process steps in Change Control be corrected retrospectively?

Process steps are generally completed with the electronic signature - corrections are not supported. However, users can redirect the process back to a previous step and reprocess it. Backtracked processes are recorded in the audit trail.

Can Change Control be evaluated?

All essential data is transferred directly to the dataset attributes. This makes it possible to perform a search. Using the created Change Control, you prepare evaluations that can be exported as Word, Excel, or PDF.

Do templates exist for actions in Change Control?

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

Can I cancel an ongoing Change Control process?

It is possible to configure the system so that processes can be canceled at any step. This requires a justification in a mandatory field. The termination can only be performed by the process coordinator. 

Are there time constraints to process steps in Change Control?

You can assign time specifications individually for each process step in the system.

Can I delegate Change Control tasks?

The process steps of Change Control can be forwarded. This checks and ensures that the recipient is authorized.

Can I see the contents of all process steps in Change Control?

Only the current process step can be edited, but all other steps can be viewed at any time.

Is it possible to change defined steps in Change Control?

The process flow in Change Control complies with the GxP regulations and has been developed in consultation with QM experts. All steps are, therefore, mandatory. However, you can display additional information and trigger actions via "Custom Panels.”

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