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Track and Trace Software Integration

Supporting security and effective data handling for compliance

Track and Trace Software Integration
Importance of Track & Trace Software

Importance of Track & Trace Software

Serialization and aggregation is a software-intensive process. The software not only controls the system hardware (printers, cameras, etc.), it also records and transmits the data generated by the serialization and aggregation process. Manufacturers have to comply with strict regulations such as CFR 21 Part 11, which our software helps to support. In addition, effective production processes, consistency in data-handling, connectivity to inventory management systems and reliable data export to 3rd parties are essential for building a robust serialization process. Our experience in developing software for track and trace applications delivers the tools your processes need in order to be successful.

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Serialization and aggregation is a software-intensive process. The software not only controls the system hardware (printers, cameras, etc.), it also records and transmits the data generated by the serialization and aggregation process. Manufacturers have to comply with strict regulations such as CFR 21 Part 11, which our software helps to support. In addition, effective production processes, consistency in data-handling, connectivity to inventory management systems and reliable data export to 3rd parties are essential for building a robust serialization process. Our experience in developing software for track and trace applications delivers the tools your processes need in order to be successful.

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Line Management Solutions

Our PCE Line Manager (PLM) software is available for serialization or aggregation. An in-depth assessment of line management needs is a core part of any serialization project plan. Every step of the track and trace process needs to be coordinated, and relevant data needs to be stored and transmitted to the necessary destinations.

If you only require serialization on a single line, our PLM Direct software provides everything needed for XML export connectivity to MES or ERP systems. Using one of these options provides line control for every printer, scanner, camera and reading device connected to the serialization process. PLM offers you flexibility in setup of your connected devices in order to fulfill different track and trace processes.

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Our PCE Line Manager (PLM) software is available for serialization or aggregation. An in-depth assessment of line management needs is a core part of any serialization project plan. Every step of the track and trace process needs to be coordinated, and relevant data needs to be stored and transmitted to the necessary destinations.

If you only require serialization on a single line, our PLM Direct software provides everything needed for XML export connectivity to MES or ERP systems. Using one of these options provides line control for every printer, scanner, camera and reading device connected to the serialization process. PLM offers you flexibility in setup of your connected devices in order to fulfill different track and trace processes.

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Supports Multiple Levels of Data Management

Supports Multiple Levels of Data Management

The data generated by the track and trace process has numerous destinations, not all of which are necessarily on-site. Data needs to move through different levels of complexity, ranging from the production line up through to global supply chain systems and central databases. The software we provide manages the creation and transmission of track and trace data from level 1 (systems on the production line) through to level 5 (cloud databases).

This data includes the order data, serial numbers, and the results of the serialization process: which codes were used and which (if any) were not. Our open communication architecture platform makes integration with Manufacturing Execution System (MES) software and Enterprise Resource Planning (ERP) software possible – providing valuable data for auditing, production efficiency and company profitability. Finally, the serialization data generated on level 1 makes it securely to government agencies and global supply chain networks, all while following standard security protocols for encryption at every step in the process.

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The data generated by the track and trace process has numerous destinations, not all of which are necessarily on-site. Data needs to move through different levels of complexity, ranging from the production line up through to global supply chain systems and central databases. The software we provide manages the creation and transmission of track and trace data from level 1 (systems on the production line) through to level 5 (cloud databases).

This data includes the order data, serial numbers, and the results of the serialization process: which codes were used and which (if any) were not. Our open communication architecture platform makes integration with Manufacturing Execution System (MES) software and Enterprise Resource Planning (ERP) software possible – providing valuable data for auditing, production efficiency and company profitability. Finally, the serialization data generated on level 1 makes it securely to government agencies and global supply chain networks, all while following standard security protocols for encryption at every step in the process.

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Secure Data Handling

The track and trace process generates a large amount of data requiring careful coordination and secure handling. For site management systems, connectivity to both inventory/ordering solutions and the production line is critical. An inability to manage this data properly will lead to difficulties in establishing the digital pedigree of your products and fail to meet the compliance standards of both industry and government regulations. 

Secure Data Handling
Site Management

Site Management

PCE Site Manager (PSM) software supports the direction and monitoring of serialization and aggregation procedures taking place in a production facility. Utilizing support for XML exports and integration with SQL and Oracle servers, our PSM software facilitates the secure transfer of track and trace data from the production line through to MES and ERP systems. PSM offers its users strong account controls and secure remote access through a mobile app for flexibility in viewing production data.

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PCE Site Manager (PSM) software supports the direction and monitoring of serialization and aggregation procedures taking place in a production facility. Utilizing support for XML exports and integration with SQL and Oracle servers, our PSM software facilitates the secure transfer of track and trace data from the production line through to MES and ERP systems. PSM offers its users strong account controls and secure remote access through a mobile app for flexibility in viewing production data.

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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.

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.