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.
The newest SoftGroup® SaTT Cloud solution provides pharmaceutical manufacturers with one or two lines the flexibility to choose a more cost-effective way to meet the requirements of Directive 2011/62/EU. With SoftGroup® SaTT Cloud, there is no need to buy additional software for reporting to the EU Hub (EMVS).
You can find more information about our SoftGroup® SaTT Cloud solution in the section below.
Serialization is a process of assignment and application of a unique, verifiable product identifier to an individual product item. Meaning, a single item can not only be identified by its product type, expiration date, lot / batch number, etc. associated with the item, but also distinguished from other items of the same type & batch.
SoftGroup® SaTT supports:
A number of tracked items can be aggregated into one container (Bundle, case, pallet, etc.), which also possesses a unique tracking number.
The SoftGroup® SaTT Line Controller software provides serialization of packaged products at Unit level. It is the software that manages the SoftGroup® SaTT Stand-alone machine.
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. It supports high quality of the printed data up to 300 packages per minute.
After completing the serialization process, the final batch and serialization data are stored in а local database and can be exported or transferred to the SoftGroup® SaTT Site Controller software.
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.
SoftGroup® SaTT Site Controller sends the batch and serialization data to the relevant SoftGroup® SaTT Line Controller. In addition, the software can be integrated with different ERP systems, allowing data transfer to international and national repositories, all through a user-friendly interface.
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 EU Hub Connector provides the technical connection between SoftGroup® SaTT Site Controller and SoftGroup® SaTT Cloud. This module ensures the security data transfer between SoftGroup® SaTT Site Controller and EMVS (European Medicines Verification System) realized by Solidsoft Reply. The scope of SoftGroup®SaTT EU Hub Connector is to realize the technical connection between the aforementioned systems.
The connection with Arvato/TraceLink will allow automatic data exchange between the Arvato/TraceLink system (Level 4) and SoftGroup® SaTT Site Controller (Level 3). The process is the following: A “request file” is generated at Level 3 for a given batch in xml format and it is automatically uploaded to a specified directory in the Level 4 system. A response is then generated at Level 4 (containing the necessary serialization data) and it is imported to Level 3 for the same batch. After finalizing and locking the serialized batch, a specific batch report (end batch report) is generated in xml format and this report is uploaded back to the specified directory in the Level 4 system.
SoftGroup® SaTT Cloud offers upload/update of Product Master Data (PMD) and Product Pack Data (PPD) to the EU HUB (EMVO). Via this Cloud solution, the MAH / Parallel distributor could select which serialized batch should be reported to EMVO. The system allows verification of status of any reported serial number and supports all possible statuses according the URS document designed by EMVO: active, expired, stolen, decommissioned, supplied, exported, recalled, withdrawn, destroyed, free sample, sample for NCA, locked. After transmission of data (from EMVO to the National Blueprint system), a confirmation message is sent to the source system. SoftGroup®SaTT Cloud will also support all incoming messages (alerts) from EMVS. Here is the full list of all functionalities of our SoftGroup® SaTT Cloud solution:
Interface for Wholesalers:
SoftGroup® SaTT Stand-alone is a carton print-and-verify module for pharmaceutical packaging lines, which provides serialization of packaged products at Device level. It can be an integrated part of an automated packaging line or serve as a stand-alone machine. The SoftGroup® SaTT Stand-alone machine is designed according to the latest GMP standards and offers highest reliability.
SoftGroup® SaTT Tamper Evident is a compact label dispenser for protection against manipulation of pharmaceutical packaging.
SoftGroup® SaTT TE is a compact labelling unit, which can be integrated into existing data matrix stations or weighing systems. Self-adhesive label seals are applied on both sides of the flap of the medicine packaging. Perforation on the labels will expose manipulation by destruction of the labels. It is recommended to use transparent and circle labels.
Use our price configurator to create your own serialization system with our SoftGroup® SaTT Stand-alone and SoftGroup® SaTT Tamper Evident modules
SoftGroup® SaTT MSM (Manual Serialization Machine) is a carton print-and-verify machine for manual pharmaceutical packing areas, which provides serialization of packaged products at Device level. It can serve only as a stand-alone manual machine. SoftGroup® SaTT MSM is designed according to the latest GMP standards and offers highest reliability.
Aggregation of bundle and case
Aggregation of pallet / Warehouse reworking station
This solution is designed specifically to meet the complex needs of the warehouse. The main functionalities of this station are aggregation at Pallet level, disaggregation and re-aggregation at the same level.
Upgrade of case packer to aggregate cases
Upgrade for the existing case packer to be able to aggregate on case level. The update includes SoftGroup® Integration Kit and full pack of Line Controlling software.
We offer the option to choose between our own hardware, as well that of other vendors according to your preferences and requirements.
SoftGroup integration with machines
Our key partnerships with well-known hardware manufacturers provide us with the opportunity to be flexible and to better meet our customers’ specific needs and strict requirements.
Our software is compatible with most of the hardware equipment available on the market, which makes SoftGroup preferable partner in serialization.
We have integration with machines from known hardware producers, such as:
SoftGroup OEM equipment
SoftGroup is using well-known equipment for its machines. We are currently using one of the best camera vision and marking systems for the pharmaceutical industry.
Our hardware equipment is compatible for working with most of the OEM equipment providers. We could customize our hardware according to the customer’s requirements.
We usually use the following quality OEM equipment vendors:
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