Regulatory Compliance Software

Meet the Global Pharmaceutical Compliance Requirements with the industry’s most comprehensive solution on the market by SoftGroup

SoftGroup® SaTT EU Hub Gateway

SoftGroup® SaTT EU Hub Gateway offers an upload/update of PMD (Product Master Data) and PPD (Product Pack Data) 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 status verification of any reported serial number and supports all possible statuses according to the URS document designed by EMVO: active, expired, stolen, decommissioned, supplied, exported, recalled, withdrawn, destroyed, free sample, sample for NCA, locked.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), there will be a confirmation message sent to the source system.

 

SoftGroup® SaTT EU Hub Gateway will also support all incoming messages (alerts) from EMVS.

EU fmd track and trace cloud services
  • Product Master Data – Create/Upload/ Update Product Master Data
  • Product Pack Data – Create/Upload/ Update product pack data
  • Pack status update (all statuses according to the EMVO transitions rules)
  • Request report
  • Incoming messages (alerts and notifications) from EMVS
  • User rights depending on groups membership

Many thanks for your interest in our brochures. Please fill out your email and we will send you the brochure shortly.

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SoftGroup® SaTT Uzbek Hub Gateway

SoftGroup® SaTT Uzbek Hub Gateway provides a connection and data exchange between the Uzbek National Track & Trace System and all supply-chain participants (MAHs, Manufacturers, Importers, Wholesale trade enterprises, etc.). The solution allows requesting and receiving cryptographic protection (crypto key and crypto signature for each serial number uploaded the final batch data) and publishing the serialization and aggregation reports concerning Government Decree No737 “Establishment of obligatory digital labelling”.

 

The system supports all possible statuses and functionality required by the National Track & Trace requirements.

softgroup cloud service regulatory software compliance uzbekhub
  • Commission / Decommission unit/multi pack
  • Aggregation / Deaggregation / Relabeling (Reaggregation)
  • Quality shipment / QC Release
  • Shipment / Receipt / Transfer
  • Import / Export
  • Withdrawal / Recall
  • Destruction / Move Destruction
  • Processing / Query result
  • Notifications (receive/move order, move owner, refusal sender/receiver, retail)

Many thanks for your interest in our brochures. Please fill out your email and we will send you the brochure shortly.

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SoftGroup® SaTT Kazakh Hub Gateway

SoftGroup® SaTT Kazakh Hub Gateway provides a connection and data exchange between the Kazakhstan National Track & Trace System and all supply-chain participants (MAHs, Manufacturers, Importers, Wholesale trade enterprises, etc.). The solution allows requesting and receiving the cryptographic protection (crypto key and crypto signature for each serial number upload the final batch data) and publishing the serialization and aggregation reports, concerning Article 7-2/12.04.2004 “About regulation of trade activity” and determining the procedure for marking and traceability of medicines in the territory of the Republic of Kazakhstan, Order No. KR DSM -11/27.01.22 “For the approval of rules for labeling of medicines and medical devices” of the Minister of Health and social development of the Republic of Kazakhstan.

 

The system supports all possible statuses and functionality required by the national track & trace regulator.

track and trace kazakhstan cloud solution
  • Commission / Decommission unit/multi pack
  • Aggregation / Deaggregation / Relabeling (Reaggregation)
  • Quality shipment / QC Release
  • Shipment / Receipt / Transfer
  • Import / Export
  • Withdrawal / Recall
  • Destruction / Move Destruction
  • Processing / Query result
  • Notifications (receive/move order, move owner, refusal sender/receiver, retail)

Many thanks for your interest in our brochures. Please fill out your email and we will send you the brochure shortly.

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SoftGroup® SaTT Kyrgyz Hub Gateway

SoftGroup® SaTT Kyrgyz Hub Gateway provides a connection and data-exchange between Kyrgyz National Track & Trace System for pharmaceutical products and medical devices – ИС ЭБД (IS EBD) and all supply-chain participants (MAHs, Manufacturers, Importers, Wholesale trade enterprises etc.). The solution allows final batch data upload and publishing the serialization and aggregation reports, concerning Resolution No.53/9.02.2023 “Implementation of a drug traceability system in the Kyrgyz Republic“, as well as Order No. 1110/20.09.2022 “Serialization and traceability process of medicines in Kyrgyzstan” and KR-DSM -11/27.01.22 “Approval rules for marking medicinal products and medical devices” of the Minister of Health of the Republic of Kyrgyzstan.

 

The system supports all possible statuses and functionality, required by ИС ЭБД (IS EBD).

kyrgyz pjarma track and trace solution
  • Commission / Decommission unit/multi pack
  • Aggregation / De-aggregation / Relabeling (Reaggregation)
  • Quality shipment / QC Release
  • Shipment / Receipt / Transfer
  • Import / Export
  • Withdrawal / Recall
  • Destruction / Move Destruction
  • Processing / Query result
  • Notifications (receive/move order, move owner, refusal sender/receiver, retail)

 

Some of the functionalities will be active after their activation by Ministry of Health of the Kyrgyz Republic in the ИС ЭБД system.

Many thanks for your interest in our brochures. Please fill out your email and we will send you the brochure shortly.

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SoftGroup® SaTT AZ Hub Gateway

SoftGroup® SaTT AZ Hub Gateway provides an automatic and secure connection and data exchange between the Azerbaijan National Track & Trace System for pharmaceutical products – Dərman Vasitələrinin Təqib və İzləmə Sistemi (DVTIS) and all participants across the supply chain. The solution allows final batch data upload and publishing of the serialization reports following the latest Azerbaijan National Regulatory Authority requirements.

 

SoftGroup® SaTT AZ Hub Gateway supports all possible statuses and functionality required by DVTIS system.

azerbaijan track and trace
  • Reporting events, required by the Bahrain National Health Regulatory Authority – Commissioning (Items, Cases, Pallets), Packaging, Shipping, Aggregation;
  • Product Transfer;
  • Product Status Updates;
  • Notifications;
  • Flexible onboarding of authorized system users;
  • Audit trail.

Many thanks for your interest in our brochures. Please fill out your email and we will send you the brochure shortly.

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SoftGroup® SaTT BH Hub Gateway

SoftGroup® SaTT BH Hub Gateway provides a connection and data exchange between Bahrain National Track & Trace System – NHRA-MVC Traceability Hub and all stakeholders (MAHs, Manufacturers, Exporting Distributors, Agents/Importers, and Dispensers, etc.). allows uploading the required product and location master data of imported or produced medicines. SoftGroup® SaTT BH Hub Gateway will support all incoming messages (alerts) from the NHRA-MVC Traceability Hub, following the latest National Regulatory Authority (NHRA) requirements. within the Kingdom of Bahrain for tracking pharmaceutical products.

 

The system will support all possible statuses and functionality, required by the Bahrain National Health Regulatory Authority and NHRA-MVC Traceability Hub.

bahrain track and trace
  • Reporting events (such as Commissioning, Packaging, Shipping, etc.), required by the Analytical Expertise Center of MOH of the Republic of Azerbaijan;
  • Product Transfer;
  • Product Status Updates;
  • Requests & Receipts Confirmations, Notifications & Alerts;
  • Outbound & Inbound documents
  • Flexible onboarding of authorized system users;
  • Audit trail.

 

Some of the functionalities will be active after their activation by the Analytical Expertise Center of MOH of the Republic of Azerbaijan in the DVTIS system.

Many thanks for your interest in our brochures. Please fill out your email and we will send you the brochure shortly.

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SoftGroup® SaTT UAE Hub Gateway

SoftGroup® SaTT UAE Hub Gateway provides a connection and data exchange between UAE National Track & Trace System – Tatmeen digital platform and all supply chain actors (MAHs, Manufacturers, Licensed Agent, Brand Owners, Wholesalers, Distributors, etc.). The solution will allow access to the product master data (PMD) of imported or produced drugs and uploading and publishing of the product pack data (PPD), including serial and aggregation reports of all packaging levels. SoftGroup® SaTT UAE Hub Gateway will support all incoming messages (alerts) from the Tatmeen Platform, concerning the last Ministry of Health and Prevention Resolution for tracking the pharmaceutical products and serialization guidelines.

 

The system will support all possible statuses and functionality, required by the UAE Ministry of Health and Prevention (“MOHAP”).

softgroup uae tatmeen cloud solution
  • Commissioning, Aggregation and Shipping
  • Hierarchy Change: Pack (Child-Parents-Packing confirmation) & Unpack (Parents-Child-Unpacking confirmation)
  • Product Transfer: Shipping, Receiving, Shipping Returns, and Receiving Returns
  • Product Status Updates: Sampling, Lost, Stolen, Damaged, Dispensed, Exported, Blocked (for Inspection, Recall, Destruction), Unblocked, Recall
  • Product Verification in Portal
  • Requests & Receipts Confirmations, Notifications & Alerts
  • Outbound & Inbound documents
  • User rights depending on groups membership

Many thanks for your interest in our brochures. Please fill out your email and we will send you the brochure shortly.

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Ready to see SoftGroup in action?

 

Book a demo and learn that SoftGroup can help you to:

 

  • Generate serial number formats to meet all requirements
  • Assign serial numbers and lot numbers to any product
  • Data verification
  • Export serialization data to subcontractors
  • Generate reports and statistics
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