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November has been an exciting and productive month for SoftGroup, filled with significant achievements, insightful content, and industry engagement. From launching a new whitepaper to exploring pivotal regulatory changes, we’ve stayed at the forefront of pharmaceutical serialization and compliance. Here’s a detailed look at what we accomplished this month.

 

 

 

Whitepaper: Serialization Compliance in Greece

 

We introduced a comprehensive whitepaper designed to guide pharmaceutical companies in navigating Greece’s unique serialization requirements under the European Medicines Verification System (EMVS). This resource delves into the role of the Hellenic Medicines Verification Organization (HMVO) and offers practical advice on ensuring compliance with national and EU regulations. The whitepaper solidifies our commitment to supporting clients in meeting complex serialization challenges effectively.

 

Learn More: Serialization Compliance in Greece

 

 

Ensuring Data Integrity with Azure and SATT PLATFORM

 

As data integrity becomes increasingly vital for pharmaceutical operations, we explored how Azure’s advanced security features and SoftGroup’s SATT PLATFORM create a robust foundation for compliance. Our blog emphasizes the importance of leveraging cloud-based solutions that ensure secure, scalable, and compliant pharmaceutical processes. Azure’s unparalleled reliability supports critical features like disaster recovery, encryption, and threat detection, reinforcing data security for our clients.

 

Learn More: Data Integrity in Pharma with Azure

 

Post-Event Season Summary

 

As the event season concluded, we reflected on our participation in key industry gatherings, including CPhI Worldwide 2024. These events allowed us to connect with industry leaders, showcase our innovative solutions, and gather invaluable insights from the pharmaceutical ecosystem. Our post-event summary highlighted the importance of collaboration and innovation as we develop tailored solutions for our clients.

 

Learn More: Post-Event Season Summary 2024

 

 

Northern Ireland’s Exit from EMVS

 

We addressed a critical regulatory shift: Northern Ireland’s departure from the European Medicines Verification System (EMVS). This development has significant implications for pharmaceutical serialization and compliance in the region. Our analysis outlines the adjustments companies need to make to align with the new requirements, ensuring uninterrupted compliance and patient safety.

 

Learn More: Northern Ireland’s Exit from EMVS

 

 

 

FDA Extends DSCSA Deadline to 2025

In a significant regulatory update, the FDA announced an extension of the Drug Supply Chain Security Act (DSCSA) enforcement deadline to 2025. We explored how this change impacts pharmaceutical companies, offering them more time to refine serialization strategies. SoftGroup continues to support clients with cutting-edge solutions that streamline compliance and optimize supply chain processes.

 

Learn More: FDA Extends DSCSA Deadline

 

 

Top Azure Security Features for Pharmaceutical Compliance

We rounded off the month by spotlighting essential Azure security features that empower pharmaceutical companies to meet stringent compliance standards. From advanced encryption protocols to AI-powered threat detection, Azure is pivotal in safeguarding sensitive data. With SoftGroup’s solutions, these features ensure our clients operate within a secure and compliant framework.

 

Learn More: Azure Security for Compliance

 

Looking Ahead

 

As November comes to a close, we’re energized by our progress and excited about what’s ahead. From product updates to regulatory insights, SoftGroup remains committed to driving innovation and compliance excellence in the pharmaceutical industry. Stay tuned for more updates as we continue shaping the future of serialization and traceability.