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?
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 of your colleagues.
Process safety
After each step, the workflow system ensures that the CC is forwarded to the person in charge. The escalation system takes effect in case of missed deadlines.
Reduction of 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 on short notice.
Reports
Create reports and statistics about your change controls.
Some features of Change Management
- Classification of the Change Control processes according to types
- Evaluation of a CC according to approval, registration or GMP relevance with consequent dealing in the dynamic CC form
- Distributor for planning, processing 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, Chapters 4 and 7
- EU GMP Guide Part 2, Section 13
Get to know our software better
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.
1st Step: Initiation
The initiation of the Change Control is done by the process responsible of the concerned department. He or she records the relevant data for Change Control. The process is then forwarded to the appointed Change Control responsible.
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
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?
What is Change Control / Change Management?
Is there a use case example for the 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.
Are there time limits for the execution 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?
What is the use for Change Control / Change Management?
What are the arguments in favor of using a change management software?
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.
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.
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