CHANGE MANAGEMENT

• Time-related analyses of change runs with graphical display of key figures on the overall status, processing status, workflow status or the number of change requests, change category, priority or the degree of effectiveness, as well as with regard to adherence to deadlines and change objects
• Provision of a so-called datamart; data pool for import and use in existing BI systems
• Role-specific dashboard for management with clear representations of meaningful or decision-relevant real-time information

• Closed and stable change management system with fully traceable change documentation across all phases and areas
• Electronic signatures and audit trails in accordance with 21 CFR Part 11 and Annex 11
• Automated emailing with timely spacing of upcoming deadlines or due dates
• Reminders and escalation mechanisms for (over) due tasks and actions
• GxP-compliant implementation incl. standard validation templates and methodology
• Easy configuration (GAMP® category 4)
• Simplifies compliance to a wide range of norms and standards
• Comprehensive authorization and access concept to ensure highest security standards
• Web-based and mobile-enabled

• Intelligent client concept for mapping international group structures
• Establishment of a company-wide change management system
• Clear management of global and site-specific standard change/measure catalogs or cross-site measures
• Redundancy-free adaptation of globally specified information to local conditions
• Language packages for international use; standard scope of delivery: DE and EN
• Tools for translating the software interface into all unicode-capable languages

In a general sense, the term “change management” refers to the need for organizations, organizational units, or departments to adapt to changing conditions. In this process, methods and measures are used to achieve the desired target state.

In the GxP-regulated environment, “change management” ensures that every change proposed, e.g., for a product, is appropriately defined, reviewed, and approved. In this context, change management is a key method for avoiding dangerous errors and for preventing consequential damage to consumers or patients.

First of all, a distinction can be made between “normal” or standard changes on the one hand and emergency changes on the other. Standard changes refer to predefined or recurrent changes which are based on experience. Usually, they are pre-authorized and documented changes with a manageable risk and a successfully applied procedure. Emergency changes, by contrast, are to be implemented directly; they are usually based on previous highly critical deviations or incidents. An Emergency Change Advisory Board (ECAB) evaluates and authorizes these changes.

Furthermore, two types of changes can be differentiated, a general change (change requests of a functional nature) and an IT change (change requests of a technical nature).

DHC VISION supports a standardized process (workflow) for the systematic and controlled implementation of all changes. These can be change requests for products, processes, systems, IT applications or documents such as SOPs. A special workflow is provided for IT changes (e.g., “new software implementation”) as the impact analysis, for instance, is carried out in a different way (e.g., impact on validation, training documentation…). This results in very broad and diverse application options. The standard workflows can be adapted to company-specific requirements by configuration. Regardless of the change object, all steps and activities are documented – from the change design to the technical and formal reviews, the impact analysis, the approval of a change, its implementation and the review of its effectiveness, and, finally, to the completion of the entire change process.

Changes usually have an impact on processes and documents (SOPs, manufacturing instructions etc.). Many people and departments are involved in the design and implementation of a change; they may even be located in different buildings or sites. Without digital support, it is hard to handle complicated and cross-system processes. In addition, changes may be triggered by external factors, which are not within the reach of the company itself; it is important to react quickly to such changes.

The use of a holistic solution automates the entire process and ensures that all changes are managed in a targeted and traceable manner. Records are kept completely electronically. It is always possible to see who did what, when, where and how. Changes, releases, approvals, verifications – everything is logged. The change management software ensures full adherence to compliance requirements.

As a web-based system (in the cloud or on premise), DHC VISION ensures that employees are informed of changes in good time; they can work from wherever they are based. Other processes such as SOP management or eDMS (modification and training of standard operating procedures) or CAPA & Deviation and Complaint Management can be integrated to create seamless processes across system components.

Change Management is closely integrated with other eQMS processes in the DHC VISION product family. If new training requirements arise from a change process, these can be covered by the Training Management module; document control in the change process is based on the SOP Management system component (document management for controlled documents or standard documents); and deviations and measures can trigger more extensive change processes, which are then digitally supported in DHC VISION Change Management and on the basis of information from the upstream processes. In sum, there is seamless integration with the other DHC VISION products; closed processes can be implemented on a uniform data basis. Quality management, quality assurance, production or IT are closely interconnected.