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Complete Track & Trace Management
Track and Trace software from METTLER TOLEDO provides complete management of the entire serialization and aggregation process. Our solutions offer flexibility, whether you have a single line with limited need for connectivity, or require software for monitoring all processes across multiple production lines. The software delivers all necessary documentation and information to meet compliance with the DSCSA in the United States and the FMD in Europe.
Full Database Connectivity
PCE Line Manager and Site Manager software feature full connectivity for all five levels of the serialization and aggregation process. Both solutions integrate with higher-level IT systems and easily connect to existing ERP, MES or cloud-based systems, ensuring easy assignment and storage of serialization data throughout the process.
Full Integration and Performance
PCE Line Manager and Site Manager software are modular offerings which can be easily scaled-up as the need arises. The pharmaceutical regulatory landscape is in a state of constant change. Based on a state-of-the-art release management, our software secures compliance with future legislation, making Track & Trace software a sound investment.
Fast and Reliable Visual Inspection
Track & Trace applications require accuracy of information to be effective. METTLER TOLEDO software verifies the presence and accuracy of serialization information such as 1D and 2D barcodes as well as human-readable text.
Documentation
Further reading to other topics related to Track & Trace Software
PCE Guide
This guide covers everything you need to know about serialization and aggregation, to implementing an effective Track & Trace programme for use in the...
Brochures
ProdX allows you to connect and control your entire product inspection management process from a single point or from multiple remote locations, elimi...
White Papers
The global threat of counterfeit medicines is growing. Quickly learn how to reliably track and trace medicinal products by integrating serialization s...
This white paper looks at the aggregation process which defines the track and trace data relationship between the parent and child.
This white paper looks at the Communicating Reliable Information and Standards for Agriculture and Logistics (CRISTAL); a communications framework for...
This white paper explains the implications of the EU directive 2011/62/EU and EN 16679 and how this will affect pharmaceutical packaging. It specifica...
Case Studies
Catalent Biologics, a leading provider of advanced delivery technologies and development solutions for biologics, turned to METTLER TOLEDO for afforda...
An early adopter of serialization technology, Artesan Pharma could offer serialization services to customers far in advance of regulatory deadlines.
R-Pharm Germany GmbH has rounded out its service portfolio with the Case Aggregation Kit from METTLER TOLEDO PCE – in combination with a compatible ca...
In this case study pharmaceutical company Medac successfully uses a combination of checkweigher and marking system to achieve serialisation requiremen...
Services
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We support and service your product inspection equipment through its entire lifecycle, from installation to preventive maintenance and calibration to equipment repair.
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Mass Calibration - Accuracy and Tracebility with ISO Norm
Calibrate your weighing process, not just your scales
FAQs
What's the Difference Between Track & Trace and Serialization?
Serialization is the marking of a product at the individual level with a unique identifying number. That number is recorded and uploaded to a centralized database where it can be checked at point of sale to establish the authenticity of the product. Track & Trace combines serialization with aggregation, establishing complete traceability of products as they move through the supply chain.
What Software is Required for Compliance with Pharmaceutical Regulations?
The software side of Track & 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).
What Does the Integration Process Look Like?
Like the Track & Trace process itself, there are two parts to the integration process. The first, and more obvious, comes from adding the hardware to the production line. This may not involve anything more than rolling the hardware up to 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 software integration is the more difficult task – the system needs to be able to communicate with the printer, the camera, and – of course – whatever database is assigning and recording serialization data.
What are the Connectivity Options for PCE Line Manager and PCE Site Manager?
Both PCE Line and PCE Site Manager software connect to Microsoft SQL Server or Oracle databases via Ethernet connection.