DUE Pharm is the named partner of SoftGroup AD
SoftGroup is a software company that provides end-to-end traceability technology. The company develops traceability systems that enable regulatory compliance and build confidence along the entire supply chain. With its adaptive solutions, companies can achieve high transparency and saver communication.
AREA OF OPERATION
DUE Pharm is operating in:
- Baltic States (Latvia, Lithuania, Estonia);
- Scandinavia (Denmark, Norway, Sweden, Finland);
- The Eurasian Economic Union countries (Kazakhstan, Kyrgyzstan, Armenia).
PHARMA SERIALIZATION
According to the global initiative to prevent low-quality and falsified products from entering the legal supply chains, specific requirements are set for assigning a unique code to the packaging of each product and printing this code on the packaging by any method.
Pharmaceutical serialization is a process of assigning a unique serial number to each pharmaceutical package, goods can be identified and tracked throughout the entire pharmaceutical supply chain. Information including the product origin, expiry date, and the batch number could be identified and associated with the serial number, enabling Track and Trace from the production cycle to the end-user. Serialization and traceability can standardize and harmonize operational processes across manufacturers, parallel distributors, warehouses, 3PLs, hospitals, and pharmacies resulting in a synchronized workflow.
SOLUTION FOR SERIALIZATION OF MEDICINES
LEVEL 1
Serialization and Aggregation Hardware
SoftGroup provides a wide range of serialization, tamper evidence and aggregation machines designed according to your specified standards, as well as global and local regulations. SoftGroup’s Team is able to manage advanced integration of serialization and aggregation hardware in existing production equipment.
LEVEL 2
Serialization and Aggregation Software
SoftGroup® SaTT Line Controller is serialization software installed on a serialization machine, which controls the process of printing and verifying process of the printed templates with and without serialization for each batch.
LEVEL 3
Centralized Serialization Software System
SoftGroup® SaTT Site Controller is a centralized serialization software system for the management of the serialization and aggregation processes. The Site management software by SoftGroup provides a complete solution for managing the whole production of the factory and preparing serialization and aggregation data for reporting to National and International Authorities.
LEVEL 4
Track and Trace Software
With SoftGroup® SaTT Communication Cloud you can securely communicate across your business network. Fully automated communication or with XML file exchange through sFTP service, we can help you to enhance your supply chain visibility by keeping your costs to a minimum and reducing human errors.
LEVEL 5
SoftGroup® SaTT Gateway
SoftGroup® SaTT Gatewayis the most user-friendly and fully automated SaaS software for meeting compliance for traceability and serialization. It fully supports the EU FMD and MDLP requirements as well as other implemented and emerging compliance regulations for each member of the supply chain: manufacturers, wholesalers, repackagers or 3PLs.
SoftGroup is a Certified Gateway Provider of the European Medicine Verification Organization (EMVO), Bulgarian Medicine Verification Organization (BgMVO), as well as a certified partner of GS1. Additionally, the company is an accredited solution provider and integrator of the CRPT system(Russia), Asl Belgisi (Uzbekistan), and IS MPT (Kazakhstan).
SOLUTION FOR SERIALIZATION OF MEDICAL DEVICES
From 26th of May 2024 all medical devices placed on the market must be in conformity with the Medical Devices Regulation (MDR) (2017/745/EU) and In vitro Medical Devices Regulation (IVDR) (2017/746/EU). And that includes mandatory requirement of serialization.
Traceability has a key role in the monitoring, supervision, and improvement of the overall quality of medical devices and in-vitro devices.
Serialization, by assigning a unique serial number to a medical device despite its manufacturing origin around the world, is the first step for a traceability solution.
Track and Trace solution
SoftGroup® EUDAMED Gateway
SoftGroup® SaTT EUDAMED Gateway (automatic connection) is a web-based service, part of SoftGroup® SaTT Cloud, that allows an automatic and secured connection, and data exchange between manufacturers and authorized representatives of medical devices, and the European database on medical devices (EUDAMED system).
SoftGroup® SaTT
SoftGroup® SaTT Labeling machine is a specially designed automatic machine for medical devices serialization with the capability to print on labels and verify the 2D Data Matrix and human-readable elements according to EU MDR requirements and GS1 standards. The machine provides second manual verification of the readability of 2D Data Matrix codes via a handheld barcode reader. The machine supports easy changeover of the label templates and different label designs.
SoftGroup® SaTT Labeling
machine with surface camera
SoftGroup® SaTT Labeling
machine with surface
camera
SoftGroup® SaTT Labeling machine with surface camera is a specially designed automatic machine for medical devices labeling and serialization according to EU MDR requirements and GS1 standards. The machine is equipped with additional automatic verification of the readability of 2D Data Matrix codes via а surface camera, grading the quality of printed data after applying the labels. The machine supports easy changeover of the label templates and different label designs.