Articles by this author:

Carla Neves

carlaneves

Carla Neves is Critical Manufacturing’s Quality Manager and Medical Device Product Owner. She enjoys long walks with her family and the connection with nature. Carla holds an Electric and Electronics Engineering Degree and her major Industry 4.0 interests are Quality Management, Automation and IoT connectivity.

Articles written by this author

Quality inspectors
Medical device manufacturing June 23, 2022
AQL in Medical Device Manufacturing and the role of MES in its implementation

The constant need to deliver a near zero-defect production for every single lot produced is a challenge and requires the most modern tools possible to make quality management both precise and cost-effective.

Medical device manufacturing March 4, 2022
MES and Integrated CAPA

In a digitized CAPA management system, actions and alarms are triggered automatically, and containment action may begin almost immediately once an event is detected.

Software validation
Medical device manufacturing November 10, 2021
DataOps and Automated Validation- Building Quality into Validation Practices

It is due to the self-actuating nature of DataOps in capturing, streamlining and enriching data that it is gaining popularity in the Regulated industry segments.

Medical device manufacturing May 6, 2021
Automated Validation: Accelerating MES Implementations in Regulated Environments

The Automated Validation approach is crucial in helping companies to reduce the time and cost of their validation efforts by at least 60-70%.