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according to the URS document designed by EMVO: active, expired, stolen, decommissioned, supplied, exported, recalled, withdrawn, destroyed, free sample, sample for NCA, locked.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.
- 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
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SoftGroup® SaTT Uzbek Hub Gateway
SoftGroup® SaTT Uzbek Hub Gateway provides a connection and data exchange between Uzbek National Track & Trace System – Asl belgisi 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 the Government Decree No737 “Establishment of obligatory digital labelling”. The system supports all possible statuses and functionality required by “CRPT TURON” LLC.
- 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)
[Blog] Uzbekistan officially meets the mandatory digital labeling of medicines
[Blog] Uzbekistan is on the way to mandatory serialization of pharmaceutical products
[Blog] Cloud Technology in 2021: Benefits of SaaS services in heavily regulated industries
[Press Release] JSC Farmak selects SoftGroup for serialization and aggregation
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SoftGroup® SaTT RU Hub Gateway
SoftGroup® SaTT RU Hub Gateway provides a connection between the Site level and IS MDLP (Chestny ZNAK track & trace digital system) allowing an exchange of information about each product. The application allows MAHs, Manufacturers and Parallel Importers to upload the product information, to request and receive the cryptographic protection (crypto key and crypto signature for each serial number) and to report serialization and aggregation numbers (SNs & SSCCs) to IS MDLP, concerning the Decree № 1556 and № 1118. The system supports all possible statuses and functionality, required by MDLP. This data exchange is realized by using web services.
- Commission / Decommission unit/multi pack
- Aggregation / Deaggregation / Relabelling (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)
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SoftGroup® SaTT Site Controller (cloud-based)
SoftGroup® SaTT Batch Management is a web-based service that allows the user to create and update serialization and/or aggregation batches, and to import the set of serial and aggregation numbers, generated by SoftGroup® SaTT SNX Management and SoftGroup® SaTT SSCC Management services. For the batch should be specified exact line and the serialization and aggregation templates, which should be chosen. When all data is filled and approved, the batch will be ready for the production process on the respective line.
SoftGroup® SaTT SNX Management
SoftGroup® SaTT SNX Management is a web-based service that allows the user to generate serial numbers for a given product. The proposed service is capable to create the pool and generating sequential or randomized serial numbers. The user has an option to create a special template with rules for serial number generation. The generated serial numbers could be downloaded in XML file format, containing the batch data. SNX Management guarantees the uniqueness of each generated SN for a given GTIN.
SoftGroup® SaTT SSCC Management
SoftGroup® SaTT SSCC Management is a web-based service that allows the user to generate aggregation sequential numbers. SSCC Management guarantees the uniqueness of each generated aggregation number.
SoftGroup® SaTT PPD Reworking Station
SoftGroup® SaTT PPD Reworking Station is a web-based service which allows the user to modify and update information (in XML format) for serialization and aggregation numbers for each batch. The service provides a possibility to decommission single serial number or set of serial numbers, entered manually or by scanning.
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- Accelerate your journey towards global compliance
- Connect and integrate with your partner’s network
- Do automatic data exchange to Authorities and partners