Track & Trace

Counterfeit prevention and product-, process- and patient safety are essential requirements in the pharmaceutics industry. Comprehensive monitoring and traceability of pharmaceutical products via track and trace, authentication, ePedigree or serialisation are statutory requirements. To comply with these guidelines, complete product identification and documentation must appear on all product packaging, from individual wrappings via product packs and delivery cartons to pallets. To ensure traceability, all types of packing material must be labelled with individual serial numbers during the manufacturing process.

Serial numbers can be encrypted and randomised to safeguard against product piracy. Required information (such as manufacturer, date of manufacture, batch number, ingredients, etc.) is usually printed onto packaging as 2D datamatrix-code ECC200 in accordance with the GS1 Standard. The system can also print text, barcodes or RFID tags. Product serialisation allows for clear identification and traceability of pharmaceutical products over their entire life cycle and at each stage of the supply chain and ensures continuous safety and protection.

QualiVision‘s Track & Trace solution combines safe database management, code-decode systems, code scanning systems and automation. QualiReader T&T is an administration and management software to support material handling. It controls and manages control- and labelling processes in packaging systems or networked packaging lines.

The customisable standard solution can be retro-fitted into existing packaging lines or integrated into new systems. QualiReader T&T is an upgradable and future-proof investment.

Features

• Fast, reliable, policy-compliant all-in-one system for guaranteed traceability
• Easy-to-use, customer-friendly graphical user interface with touchscreen
• Suitable for basic systems, multi-lines and networked large-scale systems
• Centralised monitoring and visualisation of all relevant events, alerts and operation statuses of control and print stations
• Complete logging and documentation of production processes
• Compatible with all common track and trace concepts
• Optimal integration into existing operating processes and systems
• Seamless data synchronisation with warehouse system and integration with higher-level ERP infrastructure
• Dynamic generation of individual serial numbers or reference to external data files
• Scans all customary barcodes and datamatrix-codes as well as laser RFID tags
• Scans plain text via OCR / OCV
• Various resolutions in monochrome and colour
• Integration with and data transfer to industry-standard labelling systems such as APS apsolute, Bizerba, Domino Bitjet and A400, KBA-Metronic alphaJET, Markem, Rea Jet HR, TSC, Wolke m600 advanced, Zebra
• Comprehensive statistics and reporting (fault management, saves images, results and notices/reports)
• Password protection and multi-level user authorisations in line with security policies
• Complete logging of operator interventions and electronic process documentation
• Central administration, storage and archiving of all system-, product- and formatting data
• Safe storage and safeguarding of electronic data against data manipulation or deletion
• Qualification documents are available (DQ, IQ, OQ, PQ)
• Compliant with FDA 21 CFR part 11
• Modular structure with optional extended functionality for future requirements, standard software based

Well-known track and trace standards

• ITS (Turkey)
• IFAH directive
• European EFPIA model
• Italian Bollini
• Belgian vignette
• French vignette
• ePedigree (US)