Track and Trace Software Integration
Supporting security and effective data handling for compliance
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 3r...
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 th...
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 ...
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.
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 a...
FAQ's
What software is required for compliance with pharmaceutical regulations?
The software side of 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.
Learn more about our software options:
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.
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