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.
How do you benefit from the Change Control software?
Consideration of specifications
Changes to products, processes or systems are carried out in accordance with regulatory and internal specifications.
Constant availability
Access your data at any time. It does not matter where you are.
Increased data security
Protect your data from unwanted interference by unauthorized users and from destructive forces.
Individual configuration
Let the modules be configured according to your wishes and preferences to facilitate the onboarding training for your colleagues.
Process safety
The workflow system ensures that the deviation notification is forwarded to the respective subject matter expert after each step. The escalation system takes effect in case of missed deadlines.
Reducing process costs
The costs of administration as well as the runtimes of the processes are reduced, the quality of the results is increased.
Linking to other processes
Change controls can be initiated, for example, from deviation reports (Deviation Control) or Corrective and Preventive Actions (CAPAs).
Transparency
Every authorized employee sees the current status of all CC processes – even if he or she is not involved in the process.
Central information platform
Use the d.3ecm system as your central information platform on which you can retrieve all your data at short notice.
Reports
Create reports and statistics about your CCs
Some features of Change Control
- Classification of the Change Control processes according to types
- Evaluation of a CC according to approval, registration or GMP relevance with consequent treatment in the dynamic CC form
- Distributor for planning, progressing and approving measures
- Optional return in process
- Logging of activities in audit trail
- Parallel and serial sending of tasks
- Automatic PDF creation and storage of the form in the eDMS after each step
- Referencing master data from your ERP system
- Adding documents such as digital photos to your CC form
- Initiation of the individual tasks for the further processing of the workflow
- Escalation messages both within the system and by e‑mail
- Integrated absence management
- Initiation of a document change request for a controlled document
Regulations fulfilled by the Change Control process
- ISO 9001:2015, chapter 8.5.6
- ISO 13485:2016, chapter 4 and 7
- EU GMP guideline part 2, section 13
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 (Complaints), 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’re 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 and other general reasons that distinguish us.
Frequently asked questions (FAQs) about Change Control
Can attachments be stored with a change control?
Can the predefined designations be changed?
Can process steps be subsequently corrected?
Can I analyze the Change Controls?
Are there templates for measures in a change control?
Are there time limits for the processing of the process steps?
Can a process be cancelled?
Can tasks be delegated?
Are the contents of all process steps visible?
Can the predefined steps be customized?
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The Change Control solution 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.

Document Control
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.

Training Management
Extend the “Document Control” module to actively plan and record the qualifications of your employees with our training management.

E‑learning
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.
Quick contact
Our sales team will help you promptly and gladly.