SATT Platform

Serialization, aggregation and track & trace (SATT) cloud solution
for pharmaceutical companies.
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What We Offer

Our SATT PLATFORM is an end-to-end, cloud-based solution that enables serialization, aggregation, and track & trace capabilities for pharmaceutical companies. It is fully adapted to the needs of

Marketing authorization holders (“MAHs”)
Single-site manufacturers (“SSM”)
 Multinational pharmaceutical organizations (“MPOs”)

 

Parallel distributors (“PDs”)
Contract manufacturing organizations (“CMOs”)
Third-party logistics wholesalers (“3PLs”)

The solution offers:
Easy generation of serial and aggregation numbers
Seamless data exchange
Efficient management of production processes
Secure connection to various external partners (e.g., MAHs, CMOs, 3PLs, etc.)
Bidirectional communication between internal production sites as well as with national and international authorities
Generation of all relevant external and internal reports

Serialization data management

Exceptional flexibility and customization capacity

The SATT PLATFORM provides efficient management of the serialization and aggregation production processes.

It is an end-to-end solution for all factory production lines, generating automatic serialization and aggregation reports for the authorities.


User-friendly interface with multi-language setup
Multi-market compliance management capabilities
Capacity for customization to any set of existing production processes
Easy generation of highly customized reports in a variety of file formats
Unlimited generation of serial & aggregation numbers

Supply Chain Visibility

Effortless integration with third-party systems

The SATT PLATFORM provides full visibility of the supply chain, including coverage of marketing authorization holders, parallel distributors, contract manufacturing organizations and third-party logistics wholesalers, going all the way to the distribution of final products.

 

Automatic, semi-automatic or manual, fully secured data exchange with any external partners’ systems
Smart, customized internal and external reporting
Complete adaptation of services to existing production processes
Automatic connections to critical existing IT systems (e.g., EPR, WMS, etc.)

Regulatory Compliance

EU FMD, US DSCSA, ANVISA & NMPA compliance

The SATT PLATFORM is an accredited software solution that meets the complete compliance requirements for a wide array of partners. The solution is regularly updated to reflect ongoing regulatory changes and aggregates all compliance-related information in a single place.

Prompt reporting to EMVO, including support for all events and messages
Capacity to establish a connection to any other regulatory system
Stable and reliable connection with no downtimes through regulatory updates
Product master data management
Target markets management
Wholesaler management
Product pack data management
Alert Management

PREVENTION OF COUNTERFEIT DRUGS PRODUCTION WITH SERIALIZATION, AGGREGATION AND TRACK & TRACE SOLUTIONTHE IMPLEMENTATION OF SERIALIZATION, AGGREGATION AND TRACK & TRACE TECHNOLOGY IN PHARMACEUTICAL PRODUCTION PROTECTS PUBLIC HEALTH AND AMPLIFIES BUSINESS RESILIENCE. SUCH SOLUTIONS PREVENT REVENUE LOSS, GUARD PRODUCERS’ BRANDS AND REPUTATION, AND ENHANCE OVERALL SUPPLY CHAIN VISIBILITY AND TRANSPARENCY.

The challenge

Implementing serialization and traceability technology improves human safety and ensures supply chain visibility. However, such innovation is often linked to the following:

Adapting such technology to existing production equipment, business processes and IT systems
Ensuring seamless interaction with multiple third-party systems
Avoiding expensive and time-consuming recalibrations related to ongoing regulatory updates

The solution

Pharmaceutical companies need to implement a reliable, end-to-end system that provides the following:

Advanced serialization and aggregation data management
Capacity to interact with multiple third-party systems
Secure data exchange with external partners’ systems
Seamless integration with existing internal systems
Prompt regulatory reporting to the authorities and deployment of regulatory updates through a stable connection with no downtimes

The outcome

Pharmaceutical companies that deploy the SATT PLATFORM benefit from the following:

A drastic reduction in revenue loss associated with counterfeited pharmaceutical products
Improved market reputation resulting from minimized incidents with fake drugs
Reduction of operating costs resulting from enhanced process efficiency
Improved transparency in front of internal and external stakeholders

KEY BENEFITS FROM USING MICROSOFT AZURE

To ensure high availability, maximum security and seamless scalability, the SATT PLATFORM is hosted on the future-ready Microsoft Azure cloud environment.

Data security and encryption

Automated backups & disaster recovery

Scalability without latency

DataSecurity

Data security

Given Microsoft Azure’s security-first approach to the design and development of its cloud offering, the SATT PLATFORM provides exceptional reliability and performance metrics, scalability on demand, data backup and disaster recovery capabilities, secure identity & access management and many more mission-critical features that pharmaceutical companies can fully rely on and benefit from.

EmbeddedSoftware

Embedded Software

The SATT PLATFORM’s high stability and reliability make it suitable for pharmaceutical companies’ existing production processes and systems. The platform’s deployment does not require major customization and implementation efforts. Its 5-step integration framework outlines its adaptability to existing production equipment, business processes and IT systems.

Effectiveness

Effectiveness through Innovation

The SATT PLATFORM introduces an innovative SaaS-based approach to managing serialization and aggregation production processes. Its efficient and cost-effective business model enables pharmaceutical companies to streamline their existing processes by eliminating hardware and IT maintenance costs while benefiting from rapid deployment, advanced insights and automatic updates.

33%
Data Security
33%
Embedded Software
33%
Effectiveness through Innovation

SERIALIZATION, AGGREGATION AND TRACK & TRACE SAAS SOLUTION AT A GLANCETHE SATT PLATFORM IS A COMPREHENSIVE SAAS SOLUTION WHICH OFFERS END-TO-END TRACEABILITY AND COMPLIANCE TO PHARMACEUTICAL COMPANIES WHILE LEVERAGING STATE-OF-THE-ART CLOUD INFRASTRUCTURE DESIGN.

Level 5
Regulatory Compliance Software
Regulatory Communication
Level 4
External Network Communication
Track and Trace Software
Level 3
Enterprise Communication
Site Management Software

What our customers are sayingFEEDBACK FROM OUR CUSTOMERS

"The SATT PLATFORM enables full traceability of each individual package , collective packages and pallets in supply chain. It is charatectized by high level of reliability and business integrity."
- Michal Wika
Manager Operations, Phytopharm Kleka
“SoftGroup is not just a vendor, but our partner. All companies in the pharma industry need exactly this kind of vendor and the scalable service it provides. You can count on SoftGroup to address the evolving and unpredictable needs of your business and to support your future growth plans.”
- Petr Volf
CEO, Dovema s.r.o
“What impressed us with SoftGroup was the highly flexible solutions they offer. By partnering with SoftGroup, we not only achieved EU FMD compliance, but we also benefitted from using the most robust serialization and compliance software we have seen to date. Given the specifics in our shipment process, SoftGroup's team modified their software to fully accommodate our requirements for reporting to the EU Hub.”
- Jan Mengler
CEO, VUAB Pharma
“SoftGroup provided a very clear, simple and easy-to-use technology platform and created an environment that was based on collaboration and mutual ownership. As a relatively small company, it is important to have a partner that has the capability to understand your business and its specific needs. In our experience, SoftGroup has done just that and has proven itself as a reliable and knowledgeable partner for our serialization needs.”
- Paul van Sprang
Sales and Marketing Manager, Allgen Pharmaceuticals

Configurable & Customizable Software

  • User-friendly interface with multi-language setup

  • Multi-market compliance solution

  • Adaptable & configure platform adhering to the existing production process

  • Structured customized reports, converted in the required file format

  • Unlimited serial & aggregation numbers generation

SATT PLATFORM is a SaaS solution which enables global compliances and provide end-to-end traceability for pharmaceutical companies.

  • A complete and easy for implement solution for managing all serialization and aggregation processes of the factory and automatic generation of serialization and aggregation reports to the Authorities.

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  • Automatic/Semi-automatic or manual secured data exchange with any external Partners’ systems Smart Customized Internal & External Reports Fully adapted services to the existing production processes Automatic connection to IT systems (EPR, WMS) in place

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  • Regulatory Compliance software enables EUFMD, USDSCSA, Brazil RDC and Chinese DAL compliances ensuring data integrity, connectivity and integration. The solution gives access to all your compliance information in one place for easy accessibility and manageability. Prompt reporting to the EMVO, supporting all events and messages Readiness to establish a connection to any other regulatory system

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