Track and Trace Software Integration | Secure Data Transmission

What software is required for compliance with pharmaceutical regulations?

The software side of pharmaceutical track and trace regulations require programs that possess specific capabilities. The software must be secure, it must be able to collect serialization data from each serialization point on the production line and it must be able to export that data in a format that can be added to a manufacturer's database. The manufacturer's database must in turn connect to other databases depending on regulations – it may connect to a corporate ERP system only, or it may be required to connect to the database of a government authority. From that location, the serialization data can be accessed by the various stakeholders in the process (delivery companies, warehouses, retailers). 

Our PCE Line Manager software provides specific tools to support compliance with China, Bollini, French Coding, Russia, Pre-Printed, and Linked Coding applications, as required by local regulations. Additionally, the full PCE Software supports compliance with the US FDA 21 CFR Part 11 requirement for electronic auditing capabilities.

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What does the integration process look like?

Like the track and trace process itself, there are two parts to the integration process. The first step involves adding the hardware to the production line. This could be as easy as placing the system on the production line and connecting it to a power source, or it could involve making a modification to existing equipment – for example, connecting cameras to a label printer in order to perform verification duties. The second step is connecting the software, ensuring it is communicating with the printer, the camera, and – of course – whatever database is assigning and recording serialization data.

Track & Trace Solutions | Serialization and Aggregation Systems

Track & Trace Solutions

Systems and Software for Compliant Serialization and Aggregation

Guide to Track & Trace Technology for use in the Pharmaceutical Industries

Guide to Track & Trace Technology

Building an Effective Program

OEE and Product Inspection – Free Download

OEE and Product Inspection – Free Download

Focusing on process efficiency and calculating Overall Equipment Effectiveness (OEE) can highlight areas for improvement for pharmaceutical manufacturers.

PLM Direct Software for Data Management and Serialization

PLM Direct Software for Data Management and Serialization

Ensure serialization compliance on your production line