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 IT solutions, he shares his perspective on how pharmaceutical companies can optimize their operations securely and efficiently. 

 

Why is real-time data critical in pharmaceutical operations?

 

“It’s not a secret to anyone that the pharmaceutical industry is highly regulated, and compliance with serialization regulations requires instant access to accurate data. Delays in data exchange can lead to inefficiencies and production bottlenecks – even regulatory penalties. 

Think of it like driving without real-time GPS. If you only receive directions after missing a turn, you waste time and increase risk. In pharma, delayed data can cause compliance failures, supply chain disruptions, and costly corrections. All these are issues that could be avoided with real-time insights.” 

 

What are the biggest obstacles companies face when integrating serialization systems with ERP?

 

“One of the main challenges of legacy systems is that they were not designed for real-time connectivity. This leads to data silos. In these cases, critical compliance and supply chain data remain isolated and can cause delayed decision-making. Another issue is integration concerns. Moving to digital systems requires seamless data exchange across multiple systems. Then comes the security risks. An online environment introduces cybersecurity threats, making data protection a top priority. 

Choosing a secure, cloud-based solution for centralized management systems or just serialization ones, like those built on Microsoft Azure, ensures data integrity, security, and scalability while eliminating compliance risks.” 

 

How does the ERP Integration with a centralized management system simplify compliance?

 

“When compliance data – such as serialization records, batch tracking, and audit logs, updates automatically across platforms, it eliminates manual work, reduces errors, and minimizes compliance risks. 

With real-time traceability, companies can instantly verify data accuracy and generate reports without last-minute scrambling. It’s a game-changer for audit readiness and ensures compliance without unnecessary stress.” 

 

What are your Top 5 compliance best practices/ advice for pharma?

 

“To stay ahead of compliance challenges, pharma companies must prioritize these five key areas:

1. Compliance Comes First

Build compliance into your systems from day one to avoid costly fixes later. Follow global regulations like EU FMD and DSCSA from the start. 

2. Ensure Data Accuracy

Inaccurate data = compliance failure.  

3. Real-Time Tracking is Essential

Serialization tracking in real-time prevents supply chain disruptions and ensures products are always accounted for. 

4. Security Can’t Be an Afterthought

Data protection is compliance. Use encrypted connections and role-based access to mitigate cybersecurity threats. 

5. Leverage automation

Set up real-time alerts, dashboards, and reports so compliance becomes effortless. “

 

Who Benefits Most from this Integration?

 

“It impacts multiple teams, but three key roles experience the most significant transformation: IT decision-makers. Their top concern – is security and interoperability. Their solution? – Cloud-based system (e.g., based on Microsoft Azure) to provide them with seamless data exchange and to reduce IT workload. 

The other key role is that of the Compliance Officers. Their top concern is data audit readiness. Their solution? A real-time system that eliminates manual errors and ensures accurate reporting for regulators.”

 

 

What solutions does SoftGroup offer to address these challenges?

“At SoftGroup, we developed SATT PLATFORM, a cloud-based solution built on Microsoft Azure that gives every pharma company the security and scalability needed. 

How? Make their seamless integration with ERP by standardized data models and API-driven connectivity to ensure real-time data exchange. Enterprise-Grade Security – a key differentiator. Built on Azure for data integrity and regulatory compliance. 

At the end of the day, compliance and efficiency aren’t a trade-off. With the right technology and automation, pharma companies meet regulations. Beyond that, they optimize operations. 

I’ve seen firsthand how real-time data and ERP integrations empower pharma companies to work smarter, not harder. Those who embrace secure, scalable solutions will be the ones leading the industry.”

 

 

Learn More About Secure Pharma Operations

 

At SoftGroup, we help pharmaceutical companies enhance their data security and compliance strategies with Azure-powered solutions. If you want to strengthen the security of your serialization and supply chain operations, contact us to explore how our expertise can support your business. 

 

Want to ensure your pharmaceutical operations meet compliance standards?  Contact us today!