Quality
Change Control Management
Change management is essential in a regulated environment. Policies, work instructions and engineering changes all have to be implemented without anything falling through the cracks. This is nearly impossible without an automated system.
The keys to effective change management.
Interconnectivity
Change is rarely isolated. A change in one area will affect others. On paper-based or manual processes, those areas aren't connected. This leads to miscommunication and delays. A quality management system (QMS) that is connected to other systems ensures compliance beyond the quality department.
Automation
An automated system ensures everyone knows about a change. Document routing, tracking and approval all happen automatically. When a change is needed for compliance, a system that minimizes human error by automation is essential.
Audit Ready
A change isn't compliant if you can't show it happened. A digitized system will track changes that have been made and archive older versions. This puts your organization into an audit-ready state and ensures you can maintain that state.
Training Integration
Employees need to be aware of and trained on an engineering or document change. When your quality processes are all on the same platform, any change will automatically send out training to employees.
Trusted By
Engineering Change Management (ECM)
To be compliant, manufacturers need reliable engineering change management (ECM). An unavailable part, safety concern or new regulation all mandate an engineering change. To stay compliant, avoid recalls and save on costs, companies need cloud-based, automated change management.
Change Control for Compliance
Change control is essential in regulated environments. The U.S. Food and Drug Administration (FDA) and European Commission (EC) have strict regulations for change related to products that affect public safety. Improper change management can lead to recalls later on.
Don't be afraid of change.
Improve your quality management practices with a better change control solution.
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