Control your production-related QM processes such as change controls (CC) with our digital workflows. Our integrated solutions manage your previously paper-bound process from capture to completion completely digitally. The workflow system automatically forwards the digital form to the next instance; if deadlines are exceeded, the reminder and escalation management takes effect. Of course, an absence management is also included for the task routing.
What benefits does the Change Control software offer you?
Some features of Change Management
Regulations fulfilled by the Change Control process
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The digital forms are also converted to a PDF/A in parallel. This way, employees who are not involved in the process can also gain insight into the workflow and the document can be shared with external parties if required.
What is a Change Control process?
The Change Control process is used to ensure that changes affecting products, processes and systems are carried out in conformity with regulatory and internal specifications. The aim of this process is to provide a systematic, traceable changes management.
Every action in the process is automatically documented by the system accordingly. Integrated audit trail functions ensure high traceability.
The digital form is filled out step by step and provided with the relevant entries and data. Fields with a blue background are mandatory. Predefined value sets and drop-down functions make it easy for users to fill out the form.
After processing the individual steps (1. Initiation & categorization, 2. Evaluation of relevance for approval, 3. Evaluation of relevance for registration, etc.), the workflow system automatically sends tasks and messages to the responsible agents or workflow participants. Once all steps have been processed, the workflow is considered complete.
Would you like a live webcast of the software?
Get a live insight into the possibilities of the production-related QM processes in just 45 minutes with a sample use case. Learn how you can use the solutions of d.velop Life Sciences to optimize your production-related QM processes such as complaints (Complaint), deviation reports (Deviation Control), corrective and preventive actions (CAPA) or change controls (Change Control) with our digital workflows.
33 Good reasons for a cooperation with d.velop LS
You are not convinced yet? Find out about 33 good reasons speaking for a cooperation with d.velop Life Sciences GmbH. We will show you reasons from the provider’s point of view, from the software point of view as well as other general reasons that distinguish us.
Frequently asked questions (FAQs) about Change Control
The equipment in the GMP cleanrooms must be qualified and the processes used must be validated. This means that it is defined and documented in advance which equipment is used in the manufacture of a product, how the process parameters are to be set, which ingredients are required, and much more. For example, changes can be made to devices or also processes:
- The system parameters must be changed.
- Parts or components of the plant must be renewed.
- Ingredients or quantities changed.
- Cleaning or testing procedures changed.
Customer review on the Change Management
“d.velop Life Sciences GmbH has supported us in the changeover to a new electronic quality management system in record time with professionalism and expertise. In the process, six independent document management systems were transferred to a harmonized central d.3 eQMS. The support for the implementation of validation requirements for computerized systems according to GxP and ISO requirements is excellent. The modules “Document Control”, “Employee Qualification”, “Deviation Control”, “CAPA” and “Change Control” are used worldwide at SCHOTT AG and by integrating further tools in quality management the portfolio could be improved beyond document control. We have struck up positive experiences from the collaboration and will continue the good partner cooperation with further topics.”
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The Change Control is a component of the d.velop Life Sciences solution suite. Each product is powerful on its own, but when used together they are even better.
Whether work / process instructions (SOPs), process descriptions, test specifications or other types of documents — you can create, revise and sign them all digitally with this module.
Extend the “Document Control” module to actively plan and record the qualifications of your employees with our training management.
Use the new module “E‑Learning” to train your employees digitally. Create an e‑learning course according to your wishes using Microsoft PowerPoint or integrate existing presentations.
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