Articles by tag:

Software validation

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%.

MES software
Medical device manufacturing February 8, 2021
CSA vs CSV: FDA’s New Guidance for Software Assurance

The CSA ‘represents a step-change in computer system validation, placing critical thinking at the center of the CSV process, as opposed to a traditional ‘one size fits all’ approach.’ CSA helps manufacturers achieve CSV.

Supply Chain in Medical and Pharmaceutical Manufacturing
Discrete manufacturing October 8, 2020
Fine Tuning the Pharma Supply Chain

To meet the strenuous requirements of Current Good Manufacturing Practice, if there were ever an industry segment which needs Industry 4.0 implementation, it would be the pharma industry. Let’s examine how a modern MES is able to help manufacturers in the pharma segment better manage their production and their supply chain to unleash Industry 4.0 benefits.