Change Management

»Change Control«

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

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?

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 Change Control under ‘Attachments’ for all process participants. You can configure which file types can be saved as attachments and how large the files can be.

Can the predefined designations be changed?

In the workflow administration, you can configure the names of the process steps, field names and datasets.

Can process steps be subsequently corrected?

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.

Can I analyze the Change Controls?

The essential data of a Change Control is transferred to the attributes of the data record. You can use this to search and create evaluations of the Change Controls you have created. The analyses can be exported as PDF, EXCEL or WORD documents.

Are there templates for measures in a change control?

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.

What is change control / change management?

Change Management / Change Control (CC) is a formal process within a quality management system. This aims 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.

Is there an example of use for 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 even processes:

The system parameters must be changed.
Parts or components of the plant must be renewed.
Changes were applied to ingredients or quantities.
Changes were applied in cleaning and testing procedures.

Are there time limits for the processing of the process steps?

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.

Can a process be cancelled?

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. Cancelling is only allowd for the coordinator of the process.

Can tasks be delegated?

In all process steps that follow the initiation, you can forward the process step to another person. The authorization of the recipient is checked during selection.

Are the contents of all process steps visible?

When editing a process step, only this step can be edited, but the other process steps are visible.

Can the predefined steps be customized?

The change control process flow has been structured in accordance with the GxP regulations and created in consultation with QM experts. With referehnce to 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.

What is the use for change control / change management?

In the pharmaceutical industry, but also in medicine, the qualification is a prerequisite for a license to manufacture. 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.

What are the arguments in favor of using change management software?

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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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.

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