Create, monitor, and implement your change workflows.

Change Control Software

Change control, change management, and change workflows in one software including template management, monitoring, and analysis. The change control software Change.Net is designed to provide a comprehensive overview of all change processes in your company and ensure that modifications made to products and processes are conducted in a controlled, coordinated, and cost-efficient manner. From the minutest screw to the smallest footnote in the product specification sheet or the seemingly unimportant process step at the supplier company: Change.Net makes sure that absolutely nothing is forgotten or overlooked and the quality of your products and services is safeguarded throughout even the most far-reaching change processes in your company.

Advantages of the Change Control Software

Change Control Software Change.Net
  • Centrally controlled and cross-modular change management
  • Freely definable change-workflow
  • Inclusion of all affected departments
  • Comprehensive and flexible template management
  • Assistance via knowledge base and templates when designing change processes
  • Cross-modular linkage of changes to articles, article groups, processes, documents, inspection plans etc.
  • Risk analysis, permit management, and verifications of effectiveness
  • Any number of actions can be created
  • Actions can be combined with other entities such as documents, inspection plans, FMEAs, Risk analyses, audits, etc.
  • Consistent and cross-departmental traceability
  • Comprehensive action and escalation management

Functions of the Change Control Software

All change processes in a company must be executed in a controlled manner, as otherwise there is always the risk that important factors are overlooked, or inconspicuous details are forgotten. If, for instance, a part is changed in order to achieve greater cost efficiency, weight reduction, or durability, one must always keep a close eye on all other parts that are either directly or indirectly affected thereby. Today’s highly complex production methods and the reliance on various suppliers, however, make it increasingly difficult to maintain an overview of what exactly is affected by the changing of one small part, process, or directive.

It therefore comes as no surprise, that ISO 9001, ISO 13485, IATF 16949, FDA, GMP, and other applicable standards, rules, regulations, directives, and recommendations stipulate extensive recommendations for the implementation of a comprehensive change-management-system. This is why we developed the software Change.Net – your solution for centrally controlled and cross-departmental change management.

The Change Control Software Change.Net is designed to provide a comprehensive overview of all change processes in your company and ensure that modifications made to products, machines, or processes are conducted in a controlled, coordinated, and cost-efficient manner. Any previously implemented changes are fully retraceable and can be used as future knowledge base. By using Change.Net, you can simultaneously reap the benefits of innovations and minimize the risks involved in change processes.

Because change processes often bring together the most diverse departments and responsibilities, the fully flexible application of our software begins right with the freely definable workflow. An intelligent and dynamic matrix is applied in order to determine well in advance which parties must participate in the change process. This means that a clear overview of those departments and persons who are directly or indirectly part of the change workflow can be put together right in the initial planning phase. Only after the individual departments have provided their assessments and been able to bring forward possible objections, does the actual change process commence.

Because many changes differ only due to minute details, the template management in our software allows you to use previous change workflows as templates for new product or process changes. Previously conducted research, consultations, or risk analyses can thereby be adopted directly from the previous change. If, for instance, a specific product of a product family was already changed in the past, the corresponding technical characteristics (e.g. identical materials or production steps) can be retrieved via the template and are available right in the initial planning stage of the change. The software also facilitates access to a central knowledge database that contains all previously executed changes and affiliated change details.

Individual change processes can be linked with any number or type of article, article group, process, or similar entity in a cross-modular manner. The resulting synergies actively prevent excess work and facilitate a lean and effective workflow within the management system. The same applies for individual actions, which – at the push of a button – can be combined with other entities such as documents, inspection plans, risk analyses, FMEAs, or audits.

Thanks to its scalable and flexible structure, the software Change.Net allows you to execute and monitor changes of any shape and size. The actual scope of a change is only determined by the desired number of allocated departments and workflow-steps. This means that when working with the software, it is irrelevant whether the change only deals with a minute detail or, for instance, addresses the modification of an entire production facility. The software always provides users with the complete arsenal of change management – including control processes and action tracking. This means that you can determine all individual steps and responsibilities that are to be utilized in a case-by-case fashion.

Action and escalation management in the Change Control Software Change.Net
Plan, process, and manage all change-related actions

The actions you create in the Change Control Software Change.Net can be delegated to specific departments which can then independently appoint their own internal levels of responsibility. After actions have been created and delegated, they can be precisely monitored via the software’s action and escalation management. It ensures an uninterrupted flow of information, facilitates effective processes, and provides you with everything you need for sophisticated change management.

Each CAQ.Net Module Puts the Following at Your Disposal

  • Management of systemwide actions and tasks
  • Definition of attributes for all relevant entities
  • Configuration of role concepts and access rights
  • Use of multilingual application & transaction data, incl. translation tool
  • Application in multi-tenant mode for cross-location and cross-database scenarios
  • Modification of module-specific content and interfaces
  • Creation and modification of reports and e-mail templates
  • Analysis and evaluation of systemwide data across all CAQ.Net applications
  • Data validation via Audit Trail
  • Automated data exchange with existing IT-systems and infrastructures

Standards-Compliance of the Change Control Software

  • FDA 21 CFR Part 820.30
  • FDA 21 CFR Part 820.40
  • FDA 21 CFR Part 820.70
  • FDA 21 CFR Part 210-211 (CGMP)
  • DIN EN ISO 9001
  • IATF 16949 (6.3, 8.3.6, 8.5.6, …)
  • DIN EN ISO 13485
  • DIN EN 9100
  • DIN EN ISO/IEC 17025
  • GMP
  • IFS
  • More Regulations »
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