CHANGE MANAGEMENT SOFTWARE

Digitize your change management

Optimize the efficiency of your change processes by using automated, digital workflows. Guarantee the quality of your products and services and ensure that all internal and legal requirements are reliably met.

Automated forwarding and escalation management

Consideration of internal and legal requirements

Real-time overview of all deviation processes

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Software for your change processes

Optimize your QM processes in the pane of change control (Change Control, CC) with our advanced digital workflows. Our integrated solution completely transforms your previously paper-based process into a digital format, from recording to completion.

The workflow system ensures that the digital change form is automatically forwarded to the next instance, which increases efficiency and traceability. If time is exceeded, our comprehensive reminder and escalation management system is activated so that you always have an overview. In addition, a regulation for substitutions is integrated into the task routing to seamlessly compensate for failures and ensure the continuity of your processes.

What benefits does the Change Control software offer you?

Regulatory Compliance:

Changes to products, processes or systems are made in accordance with relevant regulatory and internal requirements.

Continuous data availability

Access your data at any time and from anywhere to ensure maximum flexibility.

Increased data security

Protect your data and information from unauthorized access and external threats.

Individual configuration

Customise the modules to your specific requirements to make it easier for your employees to complete the onboarding training.

Process safety

The workflow system ensures that each step of the CC process is forwarded to the appropriate contact person. The escalation system takes effect in the event of delays.

Cost reduction

Administrative costs and throughput times are significantly reduced, while the quality of the results increases at the same time.

Integration into existing processes

Change Controls can be initiated, for example, from deviation reports (Deviation Control) or corrective and preventive actions (CAPAs).

Transparency

Every authorized employee has insight into the current status of all CC processes, regardless of their direct involvement.

Central information platform

Use d.velop documents (formerly d.3ecm) as a central platform for quick access to all relevant data.

Reports

Create comprehensive reports and statistics on all change control processes.

Digitise your processes for greater efficiency

Get to know our software better

Notebook on which the QM process Change Control of Digital Life Sciences is mapped
PDF Document

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.

dls | change control

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.

Audit Trail

Every action in the process is automatically documented by the system accordingly. Integrated audit trail functions ensure high traceability.

Form

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.

Process Steps

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.

1. 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 insight into the software?

Get a comprehensive live insight into the possibilities of production-related quality management processes within just 45 minutes using a specific use case. Learn how you can use Digital Life Sciences solutions to optimize your production-related QM processes, such as
complaints (Complaint Management), deviation reports (Deviation Control), corrective and preventive actions (CAPA) and change control (Change Control) efficiently through our digital workflows.

Some features of Change Management

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

33 Good reasons for a cooperation with Digital LS

You’re not convinced yet? 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

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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.

Change control in quality management is a systematic process that ensures that all changes are implemented and documented within a controlled and traceable framework. This process is key to ensuring consistency, transparency and product quality as well as compliance with regulatory requirements.

Change control software optimizes the change control process by automating and seamlessly documenting all the necessary steps. This software enables companies to plan, implement and monitor changes efficiently, improving traceability and facilitating compliance. This is particularly important in regulated sectors such as the pharmaceutical industry, where precise processes are essential.

A change control manager is responsible for monitoring and coordinating the change management system. His main tasks include systematically evaluating changes, working closely with various departments and ensuring that all relevant procedures and processes are complied with in accordance with regulatory requirements. The manager has a key responsibility to ensure that changes do not compromise the integrity and quality of the product or service, ensuring continued compliance with regulations.

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.

A change control form is a crucial document in the context of change management and contains essential information, including a detailed description of the change, the underlying reasons, the sections affected and the necessary approvals. It serves as structured documentation in the change control process and ensures that all relevant approvals and checks are completed before the change is implemented in practice.

Although change control and change management are closely linked, they have different focuses that are of crucial importance in production. Change Control focuses on the systematic formalization and documentation of changes. The aim is to ensure that all changes are carefully evaluated and approved. This is done through specific procedures and forms aimed at ensuring consistency and compliance.

Change management is a comprehensive concept that encompasses the systematic planning, implementation and monitoring of changes in processes, technologies and organizational structures. In production, change management plays a decisive role in the introduction of new technologies and software systems. It ensures that all employees are adequately prepared and trained to ensure a smooth transition and optimize the efficiency of processes.

Change control and change management together form a comprehensive framework for change management in production. Change Control ensures structural integrity and compliance with regulatory requirements, while change management promotes the smooth and efficient implementation of changes.

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