Solution: Structure change management with enaio®
Making changes to organizational processes and workflows is without a doubt one of the most complex projects undertaken at any company, especially if they relate to the quality and safety of products. When carrying out such a project, it is necessary to create detailed, end-to-end documentation of every change.
The best-practice solution for change management from enaio® enables you to fulfill official requirements and plan, implement, and monitor them efficiently.
The combination of workflow-managed processes and structured document storage are critical advantages. The enaio® workflow management solution reliably manages processes, measures, and reports. Conversely, vast quantities of logs, correspondence, reports, and documentation are generated despite all efforts to prevent this – and these all need to be managed centrally.
Core components of the enaio® solution
Change request
Review and assess (change board)
Manage analysis, implementation, and effectiveness audit actions
Controlling
Research and analysis
Record creation
Universal availability of key documents is constantly guaranteed.
Reliably manage processes, measures, and reports.
Easy to connect to other quality management applications from enaio®.
Archiving solutions need to uphold statutory deadlines. enaio® supports you with this challenging task.
Are you looking to find out what happened? Thanks to user-defined templates, you can individually configure when a report must be compiled and generate a report each time a change is required. In addition, all reports are securely archived.
Despite its complexity, change management is only one part of company-wide quality management. That’s why this best-practice solution is able to interact with the other solutions in the enaio® quality management suite. Documents from other applications can be interlinked with ease and, in some cases, automatically. Deviations and complaints, which often trigger changes, can also be linked. Along with that, device and test equipment data as well as the associated maintenance work can be incorporated.
Complex, event-based workflows
Managed process flow
Reminder function
Escalation management
Configurable action management for implementation
Microsoft Office integration
Risk assessments are taking on an increasingly important role when it comes to carrying out quality-related activities. Verification that a risk evaluation was carried out must be available at all times, especially when changes are made to processes.
The best-practice change management solution also supports the administration of the corresponding forms and workflow-driven action management.
Long-term, secure archiving
Templates for routine activities
Comprehensive reporting and statistical functions
End-to-end logging (audit trail) with graphic visualization
Simple electronic signature
Context-related storage of all relevant workflow data
Decisions need to be made all the time during the change process.
The answers to these questions can be found in the data and documents in the change record. You do, however, need to know that you can rely on the integrity of the data. According to the recognized ALCOA concept, data must be attributable, legible, contemporaneous, original, and accurate. With the enaio® best-practice solutions, you can rely on the fact that you will comply with these rules.
Implementation of the ALCOA concept
Change record provides an overview of processes
OPTIMAL SYSTEMS is a
Group company of
Kyocera Document Solutions.
General Remarks
Software & Services
LOCATIONS
© Copyright OPTIMAL SYSTEMS 2024. | Legal & Data Privacy | Cookie-Settings