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Process Management

QA Process has been developed to apply Business Intelligence e Data Warehouse principles to GMP & Process Data Collection, even using Reporting Functions.
These Functions are partially available on Process Control System's (e.g.: SCADA, MES, HVAC), but usually such system doesn't integrates GMP related data (e.g.: Analytical Data, environmental Data, specific GXP trends, ...).
The target of this Module is the Integration with existing platform, to obtain Regulatory Compliance significant data, and NOT the Process Control System replacement; this Module is deeply configurable, for System's Functionality, Data Entry and Configurable Interface (ETL), to abstract data by on field systems. Specific Functions makes available a sort of shared Master Batch Record Management, in combination with existing Process Control System. This module allows Electronic Batch Records and Annual Product Quality Review Management.
To better support an easy use and the maximum flexibility, the system provide the “Process Graphic Modelling”. The combination with internal tools for Risk Management Assessment, allows the users to better identify Relevant GMP/Process Steps, and to associate them:
  • Notifications
  • Event's Recording, CLAIM, Deviations, Data, Authorisation, Electronic Signature