Secure Pharma Operations: Real-Time Data & ERP Integration To provide expert insights into the challenges and solutions surrounding real-time data and ERP integrations in the pharmaceutical industry, we spoke with our Founder & CEO Venelin Dimitrov. With a strong technical background and extensive experience in compliance-driven...
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How Azure-Based Solutions Strengthen Data Security for Pharma Operations | Compliance & Protection The pharmaceutical industry is one of the most regulated industries worldwide, and the companies within it are one of the most observed. Why? Talking about patient safety puts data security as the focus....
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Italy's Serialization Update 2025: Key Compliance Changes for Pharma Companies On 28 January 2025, the Italian Council of Ministers approved a new legislative decree aligning Italy with the EU Falsified Medicines Directive (FMD). This long-awaited update introduces a two-year stabilization period, giving pharmaceutical manufacturers time to...
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Jordan FDA Extends Serialization Compliance Deadline to June 2025 The Jordan Food and Drug Administration (JFDA) has announced an extension of the compliance deadline for implementing DataMatrix codes and serialization on secondary packaging of regulated pharmaceutical products. The new deadline is set for June 30, 2025. Serialization...
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Replacing Outdated Serialization Systems: A Practical Guide for Compliance and Efficiency In the pharmaceutical industry, serialization is the backbone of compliance and operational efficiency. However, many companies still rely on outdated systems that create unnecessary challenges. Whether itโs meeting new regulations, managing complex supply chains, or...
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The Role of Data Integrity in Pharma: Why Itโs Critical for Pharma Compliance Data integrity is a cornerstone of compliance in the pharmaceutical industry, where patient safety and product quality are paramount. With stringent regulatory requirements and the increasing complexity of global supply chains, maintaining accurate,...
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Scaling Compliance and Operations with the SATT PLATFORM A Free Webinar for Pharma Professionals to Master Compliance and Operational Excellence. ย Discover how the SATT PLATFORM enables pharmaceutical companies to scale globally while ensuring regulatory compliance and operational efficiency Compliance and operational efficiency are among the most critical challenges...
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Trends for Mission-Critical Workloads in 2025: Future-Proofing Pharma Operations In the pharmaceutical industry, mission-critical workloads are the lifeblood of operations, ensuring compliance, security, and efficiency. As we move to the 2025, technologies like SATT PLATFORM are at the forefront of enabling seamless and reliable workloads for...
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Streamline Your EMVO Onboarding Process with Our Step-by-Step Guide Designed for pharmaceutical companies in Greece and Italy, our guide simplifies compliance with the European Falsified Medicines Directive (FMD) and ensures seamless integration with EMVO and NMVO requirements. Why EMVO Onboarding Matters The European Medicines Verification Organization (EMVO) onboarding...
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Nigeria Takes a Bold Step in Medicine Safety with New Traceability Rules On October 16, 2024, Nigeria made a significant move to protect its people from counterfeit and unsafe medicines. The National Agency for Food and Drug Administration and Control (NAFDAC) enacted the Pharmaceutical Products Traceability...
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Maintaining Mission-Critical Workloads in Pharma: Free Whitepaper In the pharmaceutical industry, mission-critical workloadsโlike serialization systems, batch records, and compliance processesโare the backbone of your operations. A single disruption can lead to production delays, regulatory risks, and data loss. Why Mission-Critical Workloads Matter in Pharma SoftGroupโs free whitepaper, โMaintaining...
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The pharmaceutical industry is fast-moving and unforgiving. Any downtime - from a system failure, cyberattack, or power outage - can disrupt operations, delay shipments, and put compliance at risk. Disaster recovery isnโt just a safety measure. Itโs an essential tool to protect your operations, reputation, and...
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Reliability in pharmaceutical operations isnโt just about keeping things runningโitโs about safeguarding trust, compliance, and delivering life-saving medicines. When downtime strikes, the stakes are high: production halts, critical data risks corruption and compliance with strict regulations becomes jeopardized. This is where Azure Disaster Recovery steps in,...
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At the end of November, the Authorities in Armenia released the Government Decree #1715 on the Implementation of a Pilot Project for Marking of Medicine. Pilot Project Overview The scope of the Pilot project covers pharmaceutical products and vaccines. The starting date of the project is 31...
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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, weโve stayed at the forefront of pharmaceutical serialization and compliance. Hereโs a detailed look at what...
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Serialization Compliance in Greece: A Guide to HMVO and Medicines Verification Stay ahead in the fight against counterfeit medicines with our comprehensive whitepaper, Serialization Compliance in Greece: A Guide to HMVO and Medicines Verification. This resource is designed to help pharmaceutical companies understand and navigate the...
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The pharmaceutical industry relies on trustworthy data at each step of its operations. Why? All stakeholders are named โkeepersโ of patient safety since they meet the strict regulatory standards. Here it comes the role of data integrity. Data integrity is a cornerstone of the pharmaceutical industryโs...
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It is not the first time we will declare that the events are a fundamental part of the business, providing memorable experiences that drive real business results. During the last 30 days, our team participated in three of the top events for the Pharmaceutical industry...
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Latest Updates, November 2024 Starting January 1, 2025, the UKNI Medicines Verification System (UKNI MVS) will permanently close. This closure will mark a significant shift in Northern Irelandโs pharmaceutical landscape. The decision, brought in the Windsor Framework and implemented by Regulation (EU) 2023/1182, will end all...
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In August FDA issued documents for the official extension of DSCSA in order to support the trading partners in meeting upcoming requirements. Furthermore, in October, theย FDA issued an exemption from the enhanced drug distribution security requirements for certain eligible trading partners. Discover the exemptions and...
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