Software for your change processes
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.
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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 insight into 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 Digital 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.
Some features of Change Management
Regulations fulfilled by the Change Control process
33 Good reasons for a cooperation with Digital LS
You’re not convinced yet? Find out about 33 good reasons speaking for a cooperation with Digital Life Sciences GmbH. We will show you reasons from the provider’s point of view, from the software point of view and other general reasons that distinguish us.
Customer review on the Change Management
“Digital Life Sciences GmbH has supported us in the changeover to a new electronic quality management system in record time with professionalism and expertise. Six independent document management systems were transferred into one harmonized central d.3 eQMS. The support in implementing the validation requirements for computer-based systems according to GxP and ISO requirements is excellent. The modules “Document Control”, “Employee Qualification”, “Deviation Control”, “CAPA” and “Change Control” are globally operated at SCHOTT AG and by integrating additional tools in quality management, the portfolio could be improved beyond Document Control. We are building on the positive experiences of the cooperation and will continue the good partnership and good cooperation with other topics.”
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The Change Control is a component of the Digital 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 the document control software.
Use the new software “E‑Learning” to train your employees digitally. Create an e‑learning course according to your wishes using Microsoft PowerPoint or integrate existing presentations.
Frequently asked questions (FAQs) about Change Control
If additional files are required for a process, attachments can be uploaded in all process steps and linked to the current process. The attachments are stored under a corresponding document type in the DMS and can be viewed in the Change Control under ‘Attachments’ by all process participants. You can configure which file types can be saved as attachments and how large the files can be.
In the workflow administration, you can configure the names of the process steps, field names and datasets.
In principle, a process step is completed with an electronic signature and can no longer be corrected. With the function ‘Step back’ the process can be returned to a previous process step. The user who has completed this step receives it again for editing and the process continues from this step. Any return to a previous step is recorded in the audit trail.
The essential data of a Change Control is transferred to the attributes of the data record. This allows you to search and analyze the Change Controls you have created. The analyses can be exported as PDF, EXCEL or WORD documents.
Having entered a measure, you can save it as a template in the measure table. The templates are available for insertion in a Change Control. The due date for the measure is calculated based on the duration entered in the template.
Change Management / Change Control (CC) is a formal process within a quality management system. The aim is to ensure that all changes to a product or process are carried out in a controlled and coordinated manner and that the quality of the product is maintained despite the change.
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.
In the administration, time specifications can be entered for each process step. Reminder messages are sent before the process steps are due. The reminder message is sent to the processor of the task, the coordinator and the configured group that is to be informed about the reminder (for example, QA). A reminder is sent with the configured subject.
It can be configured so that the process can be cancelled at any process step. For the cancellation, it is required to indicate a reason in a mandatory field. Only the coordinator of the process is allowed to cancel.
In all process steps that follow the initiation, you can forward the process step to another person. The recipient’s authorization is checked during the selection.
When working on a process step, only this step can be processed, but the other process steps are still visible.
The Change Control process flow has been designed in accordance with the GxP regulations and created in consultation with QM experts. Against the background of the validation documentation, the process steps are therefore mandatory. However, each process step contains a ‘Custom Panel’, which can be used to display further information or initiate actions.
In the pharmaceutical industry, but also in medicine, the qualification is a prerequisite for a manufacturing license. Significant changes to qualified equipment always result in subsequent re-qualification. Those responsible must decide whether changes are necessary based on a risk analysis. In addition, the question must be answered as to how the change affects the quality of the product and which qualification tests must be repeated.
Compliance with partial regulatory requirements is simplified or made possible in the first place, and the corresponding risks are minimized. Change processes are standardized and traceable. Documentation requirements can be met by default. Employees at different sites can work on the same change without having to wait for documents by mail.
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