Change Control Software

Change workflows
across departments

Scalable
change processes

Documentation & traceability
of all changes

Control Change Processes Centrally

The change control software Change.Net is your solution for centrally controlled and cross-departmental change management. The software 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.

Functions of the Change Management Software



Scalable change processes
Implementation of all change processes with any number of steps, actions and questionnaires
Wizard-led creation of changes & template management
Create changes easily via wizard and use flexibly definable templates when designing change processes
Cross-departmental change workflow
Centrally controlled change management with freely definable change workflow, incorporating different departments and responsibilities
Approve changes & assess risks
Option for risk assessment and approval obligation for individual change steps
Monitoring & traceability
Create, delegate and monitor interdisciplinary actions with definition of target date and priority for consequent processing and traceability
Involvement of all employees
Access via platform-independent web application
Evaluations and reports
Record and evaluate information and generate ready-to-use or customized reports at a click

Access to changes also possible via browser

Efficient processing of questionnaires and actions

Management of change costs for later evaluation

Create changes easily via wizard

Employee action list

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Cross-Modular Functions

Integration of project-relevant documents from the Document Management Software QBD.Net
Cross-modular linkage of changes with articles, processes, inspection plans, FMEAs, audits etc.
Action tracking via the task and escalation management JobControl.Net

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 »