Pharmaceutical labeling systems must address the FDA's CFR 21 Part 11 guidelines.
Corner Office Consulting has designed a number of Middleware labeling applications
that passed FDA audits.
While CFR 21 Part 11 guidelines must be addressed, each pharmaceutical middleware
labeling application is unique to the manufacturing and packaging process. For example:
At BD Bioscience (see the Project List), SAP generated orders for vials of product are
processed on a rotary labeling machine with PLC and vision interfaces. At Bausch & Lomb
Surgical, individual cells manufacture and package lens products that require extensive
on-demand tabletop label printing control based on AS/400 generated orders.
The FDA's latest requirement for unit dose bar coding will create significant product
labeling issues.
Through partnerships, Corner Office Consulting can provide a single source
for complete systems including innovative and effective print-and-apply labelers, custom network
and ERP interfaces, plus PLC, vision and product handling integration.
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