Deviation Management

Deviation Management


Introduction

MyBlueLabel Deviation Management provides the functionality of creating, investigating, tracking and closing deviations for IT systems, processes and/or procedures. Corrective Action / Preventive Action (CAPA) must be planned and approved before they are implemented to close out a Deviation.

The Deviation is linked to the Inventory, and at the same time linked back to the trigger of deviation and forward to the CAPA associated with the deviation. This single solution ensures full traceability.

 

Module Highlights

Document Deviation

With the module your company can follow up and correct non-compliant incidents and activities. This could be procedures not being followed, changes made without change request or a system and/or associated component malfunctions.
 

Immediate Action

The Root Cause analysis of the Deviation in place can enable immediate action on how to stop the deviation and continue production. Using Corrective Actions afterwards will ensure that the deviation is properly closed. Preventive Actions will ensure that the deviation will not be reoccurring.

Process Optimization

Your company will achieve immediate insight, as the modules are interlinked. The quick identification of the flow, from what led to the deviation to the corrective action gives you a complete overview and enables a smooth remediation process.
 
The Deviation Management workflow within MyBlueLabel are as follows:
Raise Deviation – Observation, Investigation, Review Deviation (CAPA)
Internal, Review Deviation  (CAPA) Independent, Approval for Realization, and Deviation Approved.