A system that can be used for the most complex batching processes which require a high level of flexibility. Built-in security and material management capabilities including material consumption, movements, and inventory levels contribute to a comprehensive Electronic Batch Record (EBR) and reduce the cost to comply with industry regulations.
Examples of electronic records include product and raw material specifications, bills of material, recipes, SOPs, laboratory instrument data, master production and batch records, equipment set up configurations and maintenance logs.
A system that provides the capability to manage, enforce and document processes cross-company, replacing manual processes and paperwork with electronic workflows. It encompasses everything from routine operations to escalated responses to critical plant operating conditions.
Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. Ensuring that cGMP related data is accurate, trustworthy and reliable throughout the data life-cycle and ensuring once recorded, data cannot be altered. Stringent regulations are in place with the rise in violations. Global Regulators are focused on Data Integrity and more specifically about the data quality and data storage practices. From 2010 to 2012 – only 5 drug manufacturers were cited for data integrity violations. But from 2013 to 2015, 24 were cited and its only increasing.
The Schneider Electric industrial software business and AVEVA have merged to trade as AVEVA Group plc, a UK listed company. The Schneider Electric and Life Is On trademarks are owned by Schneider Electric and are being licensed to AVEVA by Schneider Electric.