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INTRODUCTION

SoftGroup® SaTT (Serialization and Track & Trace) is an integrated mass serialization system for centralized management of pharmaceutical packaging lines. It is a scalable, cost-effective and ‘smart’ solution, which can be customized to enterprise-specific needs. The system allows full traceability of any single or aggregate packaging unit within the supply chain. SoftGroup® SaTT complies with GS1’s Electronic Product Code Information Services (EPCIS) standard for holding and communicating serialization-based events, ensuring interoperability with existing systems.

ADVANTAGES

  • Optimized production workflow
  • Improved quality control
  • User-level support (e.g. planners, technicians, administration and management)
  • Digital signature and audit trail
  • User friendly and interactive interface
  • GS1 standard code and 21 CFR Part 11 compatible
  • Smooth integration with different:
    ◦ types of packaging lines
    ◦ printing and marking technologies
    ◦ verification technologies (machine vision)
    ◦ enterprise (ERP) and manufacturing (MES) systems
  • Easy installation and optimal integration

KEY FUNCTIONALITIES

  • Layout template management (labels, EBR, etc.)
  • Management of serialization numbers in operations
  • Management of modular aggregation (e.g. item, bundle, case, pallet)
  • Open for integration with centralized Track & Trace repositories
  • Handling of packaging orders and batch information
  • User rights management
  • Handling of data for mass serialization and aggregation processes:
    ◦ generation of sequential or random serial numbers
    ◦ support of multiple serial number formats
    ◦ providing serial number blocks and lists to packaging lines
    ◦ recording of used and unused serialization numbers
  • Packaging line performance management
  • Analysis of OEE (Overall Equipment Effectiveness) for packaging processes
  • Real-time data exchange between integrated systems and SoftGroup® SaTT

Family of Products

SoftGroup® SaTT offers an exceptional scalability through its family of products to ensure that pharmaceutical manufacturing companies benefit from a cost-effective mass serialization solution without compromising performance, control and security.

SoftGroup® SaTT Stand-alone machine is a carton labelling module for a pharmaceutical packaging line, which provides serialization of packaged products at unit level. It can be an integral part of a complete packaging line or serve as a stand-alone machine. SoftGroup® SaTT Stand-alone machine is designed according to the latest GMP standards and offers highest reliability.

Functionalities

  • Front/back labelling
  • Dynamic carton marking
  • Prints, reads, and verifies 1D & 2D codes, geometrical shapes and logos
  • Prints Data Matrix and human-readable codes
  • Verifies and grades the printed information
  • Ejects faulty cartons

SoftGroup® SaTT Stand-alone machine basic components include

  • Server – computer system with Windows OS
  • Monitor (touch screen)
  • Printer – can have more than 1 printing head
  • Camera – one or more than one
  • Ethernet switch (PoE)
  • PLC (Programmable logic controller)
  • Barcode scanner
  • Compact footprint
  • Balcony-style structure
  • GMP compliant construction
  • User-friendly and password protected human machine interface (HMI)

Conveyor system

  • Carton sizes:
    ◦ Width: 30-90 mm
    ◦ Height: 15-90 mm
    ◦ Depth: 80-170 mm
  • Fixed bottom belt
  • Adjustable top belt
  • Side guides
  • Rotary pulse encoder
  • Front or back 2-axis adjustable mounting kit for printing head and camera (additional software options for adjustment on the third direction)
  • Ejector with collecting container, air pressure: 6 Bars
  • Line speed: 300 cartons/min
  • Electrical control cabinet made out of stainless steel with 4 winding feet
  • Light tower
  • Optional back or front 2-axis adjustable mounting kit for second print head and camera
  • Optional ejector (depending on carton’s form and weight)
  • Optional guide rollers

Solution for control of a complete packaging line

SoftGroup® SaTT Line Contoller is a software system, which controls the entire packaging line (starting, stopping and by-passing of Labeling, Bundle, Case, Pallet modules, etc.) and provides serialization and aggregation of packaged products at line level.

SoftGroup® SaTT Line Contoller software starts the serialization process on item level after the carton is filled. It prints and verifies the batch and serialization data provided by SoftGroup® SaTT Line Contoller or by centralized management system and updates in real time SoftGroup® SaTT Line Contoller SN database. It supports high quality of the printed data even at fast production speeds.

After completing the serialization process, the final batch and serialization data are stored in а local database and can be exported.

Functionalities

  • SoftGroup® SaTT Line Contoller software can be used as a stand-alone machine or as a part of a centralized management system that manages all of the lines in the plant
  • The serial numbers can be generated by the SoftGroup® SaTT Line Contoller software or delivered by a centralized management system to the line database
  • The software uses the local database that stores all of the working data (batch and serialization)
  • All data can be exported from the database to another system
  • The software allows importing a list of serial data into the database and using them to define a batch
  • The software supports a template functionality (a template can be added for each batch). SoftGroup® SaTT Line Contoller uses the needed working files (printer and camera files) for managing the line process according to the selected template
  • SoftGroup® SaTT Line Contoller works with templates with or without serialization for the batch
  • SoftGroup® SaTT Line Contoller supports Audit Trail functionality
  • The printing system prints human readable values and 2D Data Matrix code
  • The vision system reads and recognizes human readable values and 2D Data Matrix code
  • The ejecting system recognizes and ejects faulty printed cartons and omits correctly printed cartons
  • The software complies with GS1 standard and 21 CFR Part 11 regulation

Supported Data – printing and verification

  • CIP / GTIN / NTIN
  • LOT / Batch number
  • Expiration date
  • Manufacture date
  • Price
  • Serial numbers
  • 2D barcode (Data Matrix or other type according to GS1 standards)

Usage as part of centralized management solution

If SoftGroup® SaTT Line Contoller is used as a part of centralized management solution, all of the batch information (including serialization for this batch) will be sent by a centralized management system. This usage offers the following functionalities:

  • Batch selection from a list of the loaded batches for a line
  • Line management (start process, stop process)
  • Device Management (printer setup, camera setup)
  • Line setup option
  • Selection of working mode (“Line setup mode”, “Transport mode”, “Production mode”)
  • Preview of line process

Stand-alone usage

If SoftGroup® SaTT Line Contoller is used as a stand-alone machine, the software offers batch setup that includes different serialization options. This usage support an internal serialization process that is compatible with the centralized management system.
Advantages of SoftGroup ® SaTT Line Controller

  • One point for controlling the entire line
  • Sets up all of the serialization options before generation of serial numbers
  • Supports sequential and random serial numbers
  • Sets up and controls all connected devices (printers and cameras)
  • Gathers the information from the connected devices
  • Allocates coding information to the different printers and cameras
  • Detects and handles failures (different alarm messages shall be displayed on the operator screen)
  • Records events and warnings of the batch and the serialization process
  • Supports different security levels

Enterprise solution for control of all packaging lines

SoftGroup® SaTT Site Controller is an integrated mass serialization software system for centralized management of pharmaceutical packaging lines. It controls all packaging lines and their modules, regardless of the ERP system, serialization repository, machine vision technologies and packaging automation deployed across the plant.

An external central management system sends the batch and serialization data to SoftGroup® SaTT Site Controller, which stores it in its Batch Info and SN databases. SoftGroup® SaTT Site Controller allows the user to allocate the batch to a specific line depending on production capacity and other performance indicators. SoftGroup® SaTT Site Controller sends the batch and serialization data to the relevant SoftGroup® SaTT Line Controller.

SoftGroup offers an outstanding functionality of SoftGroup® SaTT Site Controller – the system allows allocation of the batch to multiple packaging lines and distributes the batch and serialization data simultaneously to all of them. This significantly decreases the batch production time and increases the production performance.

SoftGroup® SaTT Site Controller includes

  • Serialization Manager (management, generation, storage, import/export of serial numbers)
  • SoftGroup® SaTT Line Controller software for each packaging line in the plant
  • Electronic Batch Records (EBR) – very important feature for data management. Through the EBR functionality, the SoftGroup® SaTT Site Controller software provides to the SoftGroup® SaTT Line Controller software all necessary information for setup and management of the packaging line
  • OEE reporting for the entire plant
  • Site Reworking Station

Functionalities

  • Implements EBR for the plant
  • Ensures tight and seamless exchange of packaging data between the lines and integrated systems within the plant based on the EPCIS standard
  • Manages and deploys all packaging information from one centralized site level, instead of an inefficient line-by-line approach
  • Receives production orders directly from the integrated systems (ERP, MES, etc.), automating the start lot process
  • Ensures the uniqueness of serialization numbers at pallet, case and/or unit level. SoftGroup® SaTT Site Controller assigns serialization number ranges to packaging lines, and generates an initialization event. Centralized management of serialization numbers ensures non-repudiation across multiple lines
  • Supports multiple serialization number formats. SoftGroup® SaTT Site Controller can generate unique serialization numbers using any standard, including GTIN and SSCC
  • Real-time OEE reporting and charting

Enterprise solution for control of all sites

SoftGroup® SaTT Enterprise Controller is an integrated mass serialization software system for centralized management of pharmaceutical packaging lines. It controls all sites, regardless of the ERP system, serialization data repository deployed across the enterprise.

SoftGroup® SaTT Enterprise Controller imports the batch data from the head quarter (HQ)’s ERP system via its Import/Export Module and stores it in its Batch Info Database. (Based on open standards, the Import/Export Module can be easily customized to communicate with different ERP systems and customer specific data configurations.) The Serialization Manager generates the serial numbers and stores them in the SN (serial numbers) Database. The Enterprise Controller sends the batch and serialization data to the Site Controllers.

By using the Enterprise Controller, the production manager at the HQ sends the batch and serialization data to SoftGroup® SaTT Site Controller, which stores it in its Batch Info and serial number databases. By using the Site Controller, the production manager at the site allocates the batch to specific line depending on production capacity and other performance indicators. The Site Controller sends the batch and serialization data to the relevant SoftGroup® SaTT Line Controller.

SoftGroup® SaTT Enterprise Controller includes

  • Import/Export module
  • Serial Manager (management, generation, storage, import/export of serial numbers)
  • Enterprise controller
  • Serial number database
  • Batch info database

Functionalities

  • Ensures tight and seamless exchange of packaging data between the sites (Plant A and Plant B) and integrated systems within the plants based on the EPCIS standard
  • Manages and deploys all packaging information from one centralized enterprise level, instead of an inefficient site-by-site approach
  • Manages and deploys all packaging information from one centralized site level, instead of an inefficient line-by-line approach
  • Receives production orders directly from the integrated systems (ERP, MES, etc.), automating the start lot process
  • Ensures the uniqueness of serialization numbers at enterprise level
  • Supports multiple serial number formats. SoftGroup® SaTT Enterprise Controller can generate unique serial numbers
  • OEE reporting and charting

SoftGroup® SaTT is developed with a variety of pharmaceutical packaging lines in mind. This allows smooth integration of the system in enterprise-specific environment.

SoftGroup® SaTT enables pharmaceutical companies to leverage real-time data exchange between the business administration and production levels to increase operational efficiency. It can be integrated easily into EPCIS compliant systems (such as SAP, Oracle, etc.) to enable serialization and Track & Trace not only within the company but also within the extended supply chain, no matter what platform third parties employ.

To minimize business and technology risks, SoftGroup ensures that all integrated systems will be synchronized with SoftGroup® SaTT road map and release strategy, and that the system is implemented within the framework of SoftGroup® SaTT software implementation methodology.

  • Business analysis including process definition, workflow analysis, system requirements and detailed design
  • Project planning and scheduling
  • Implementation including management and troubleshooting
  • On-site training
  • Documentation for all system users
  • Help desk support for questions and emergency troubleshooting

Problems We Solve

SoftGroup® SaTT is an integrated mass serialization system for pharmaceutical manufacturers and distributors, which allows tracking of individual items throughout the supply chain. It reduces costs, enables anti-counterfeiting measures, provides regulatory compliance and adherence to GS1 standards, and can be customized to enterprise-specific needs.

Although serialization is a major topic for the pharmaceutical industry, other sectors can also benefit from tighter product control and traceability offered by item-level serialization of massproduced products. Some of these sectors include:

  • Food products and supplements (without modification)
  • Cosmetics (without modification)
  • Washing, cleaning and disinfectant products
  • Phyto and other highly toxic chemicals
  • Packaging of toys

SoftGroup® SaTT solves current and pending business problems for pharmaceutical manufacturers and distributors, helping them comply with world regulations and requirements, and mass serialization standards.

  • Prevents the introduction of counterfeit, substandard, misbranded, mislabeled, stolen or expired pharmaceutical products
  • Facilitates the identification of counterfeit, substandard, misbranded, mislabeled, stolen or expired pharmaceutical products
  • Provides accountability for the movement of pharmaceutical products by supply chain participants
  • Improves efficiency and effectiveness of recalls
  • Improves brand protection and consumer confidence
  • Ensures compliance with national requirements and global standards
Serialization

Serialization is the process of assignment and application of a unique, verifiable product identifier to an individual product item. This means that a single product item can not only be identified by its product type, expiration date, lot/batch number, etc. associated with the item, but also that any single item can be distinguished from other items of the same type and from the same batch.
SoftGroup® SaTT supports different serialization number types

  • Sequential series of unique numbers
  • Random series of unique numbers

Serial number uniqueness

SoftGroup® SaTT manages the serial numbers uniqueness per product number (CIP / GTIN / NTIN).
Other serialization options

  • The serial numbers can consist of up to 20 characters, according to GS1 standard
  • The serial numbers can be set in what range to be generated (“Start from”, “End to”)
  • The serial numbers can be set with Prefix
  • The serial numbers can be set with Suffix
  • The serial numbers can be set with a different length
  • Possibility to set a specific quantity of the generated serial numbers
  • Possibility to set different characters that can be included/excluded in the generated serial numbers (for random serialization only)
  • Possibility to set with what step to generate sequential serial numbers (for sequential serialization only)

SoftGroup® SaTT supports different serialization mediums

  • 1D barcode
  • 2D barcode
  • Human readable
Aggregation

SoftGroup® SaTT covers the process of associating the uniquely serialized product items to a higher packaging level (bundle, case, pallet, etc.) also having a unique serial number and recording this association.

Track & Trace

The term Track & Trace is used to define the process of determining the current and past locations and other information of the serialized products. SoftGroup® SaTT offers functionalities that allow full traceability of any single or aggregate packaging unit within the supply chain.

In terms of business operation, serialization means putting a serial number on a product. On the other side Track & Trace process captures and records the association and aggregation of the serial numbers. This needs to be repeated each time shipping and receiving occurs and when the pharmaceutical product is dispensed to the patient.

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