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
- 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.
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
- More Regulations »