Manufacturing & Automation Systems
The shop floor generates more GxP data than any other area of a pharmaceutical facility, and it is frequently the weakest point in a data integrity program. PLCs, historians, and SCADA systems often predate modern Part 11 compliance expectations. MES and EBR implementations are complex, and data transfer between systems creates verification gaps. This pillar covers how to manage data integrity across manufacturing automation realistically.
Articles in this pillar
GxP Manufacturing and Laboratory Systems: MES, SCADA, LIMS, CDS, and ELN
How the major GxP informatics systems, MES, SCADA, DCS, PLC, historians, LIMS, ELN, and CDS, generate and manage regulated data, their specific data integrity risks, and how 21 CFR Part 11 applies on the shop floor.
MES, EBR, SCADA, and the Shop Floor: Data Integrity in Manufacturing Automation
How data integrity requirements apply to manufacturing automation systems, MES, electronic batch records, SCADA, DCS, PLCs, and historians. Where the compliance gaps are and how to address them.
Automation Systems Validation: PLC, SCADA, DCS, and Interface Controls
Validation of automation systems in pharmaceutical manufacturing, PLC, SCADA, DCS, MES interfaces, recipes, alarms, audit trails, and what regulators expect from batch manufacturing control systems.