CHANGE MANAGEMENT SOFTWARE

• Can I analyse the Change Controls?

The essential data of a Change Control is transferred to the attributes of the data record. This allows you to search and analyse 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.

• Can the predefined designations be changed?

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

• Can the predefined steps be customised?

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.

• Are the contents of all process steps visible?

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

• Are there time limits for the execution of the process steps?

In the administration, time limits 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 attachments be filed under 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 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.

• Can tasks be delegated?

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

• 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 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. Only the coordinator of the process is allowed to cancel.

• What is Change Control/Change Management?

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.

• 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.

• What is the definition of Change Control in Quality Management and why is it important?

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.

• How does Change Control software support the Change Control process in a corporate environment?

Change Control software optimises 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.

• What role does a Change Control manager play in a Change Management System?

A Change Control manager is responsible for monitoring and coordinating the Change Management System. Their 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.

• What is the use of Change Control/Change Management?

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.

• What are the arguments in favor of using a Change Management software?

Compliance with partial regulatory requirements is simplified or made possible in the first place, and the corresponding risks are minimised. Change processes are standardised 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.

• What are the main components of a Change Control form and how is it used in the Change Control process?

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.

• What are the main differences between Change Control and Change Management in production and how do they complement each other?

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 formalisation 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 organisational 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 optimise 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.