Security gaps in pharmaceutical IT systems can lead to serious consequences. One of the most damaging cyberattacks in the industry struck Merck & Co. in 2017, when malware disabled 30,000 computers globally and halted production, resulting in $870 million in losses. In such a highly regulated field, maintaining a resilient IT infrastructure is not just beneficial but essential for survival.
Despite the growing urgency, AI-powered enterprise software is still rare in the sector, with adoption below 1 percent in 2024. However, experts expect this figure to rise to 33 percent by 2028, highlighting the fast pace of digital transformation in pharma IT. At the same time, unresolved production issues continue to cause delays, compliance failures, and unplanned costs.
This article explores how top pharmaceutical facilities are modernizing their IT systems to meet these challenges.
Regulatory Compliance in Pharma IT Systems
Pharmaceutical companies must follow strict regulatory requirements for their IT systems in global markets. These regulations are not optional. They are the foundations of pharma IT operations and directly affect patient safety, data integrity, and business continuity.
FDA and EMA Requirements for IT Infrastructure
The FDA and European Medicines Agency set detailed frameworks that govern pharma IT infrastructure. The FDA’s 21 CFR Part 11, to name just one example, lists criteria for electronic records and signatures to ensure they’re as trustworthy as paper records. This rule covers the whole computerized system, including hardware, software, peripheral devices, personnel, and documentation.
The EMA released its “Guideline on computerized systems and electronic data in clinical trials” that took effect from September 2023. This guideline requires biotech and pharmaceutical companies to verify compliance when their staff access electronic data. It focuses on data integrity through ALCOA++ principles and tackles modern challenges like:
- Cloud solutions implementation
- Data migration processes
- Electronic signatures replacing wet ink signatures
- AI integration in clinical trials
IT infrastructure qualification has become crucial because infrastructure elements can affect regulatory data integrity, availability, and confidentiality. ISPE GAMP guidance states that GxP applications’ validated status might be compromised if the IT infrastructure isn’t in a proven state of control.
HIPAA Compliance in Clinical Data Management
Pharma IT solutions must also protect patient data through HIPAA compliance. This law sets national standards for electronic healthcare transactions and tackles vulnerabilities in clinical data management.
HIPAA breaches have affected over 176 million patients in the United States. Most incidents stem from employee negligence rather than external hacking. The HIPAA Security Rule requires three key safeguard categories:
- Administrative safeguards: Policies, procedures, and training programs that ensure regulation awareness
- Physical safeguards: Access controls that protect systems with patient data
- Technical safeguards: Technologies that protect electronic health records
HIPAA also requires pharmaceutical companies to implement risk assessment processes. These processes assess potential threats to protected health information’s confidentiality, integrity, and availability. This risk-based approach helps companies choose security measures that match their size, capabilities, and specific threats.
Overcoming Legacy Infrastructure Limitations
Many pharmaceutical companies are still held back by outdated infrastructure, despite years of investment in their facilities. Aging IT and OT systems continue to slow innovation, limit efficiency, and create operational bottlenecks.
These are some of the most common issues caused by legacy systems:
- Limited remote management capabilities: Older infrastructure often lacks remote access features, forcing IT teams to be on-site for troubleshooting and maintenance. This became a serious concern during the COVID-19 pandemic, which accelerated digital transformation timelines by nearly a decade. Pharma IT environments are spread across offices, labs, clinical sites, and production plants, making centralized management difficult and increasing the risk of inconsistent standards and security practices.
- Lack of visibility in outdated manufacturing systems: Legacy systems often operate in silos, with little to no integration across departments. Outdated ERP platforms cannot track profitability or manufacturing costs in real time, leading to poor coordination and overstocked inventory. Adopting modern OEE software manufacturing solutions can help close these visibility gaps by providing real-time performance metrics and actionable insights across production lines.
- Challenges in integrating modern IT solutions: Siloed databases and fragmented systems make interoperability difficult. These barriers slow clinical trials, raise maintenance costs, and block access to newer technologies like AI and advanced analytics. While 40 to 50 percent of leading pharma firms have invested in modernizing IT applications, many still struggle to see measurable returns. Integration middleware can help connect old systems with new ones, but a piecemeal approach to upgrades often leaves critical gaps in the data pipeline.
Cybersecurity and Data Protection in Pharma IT
Pharmaceutical operations face growing cybersecurity threats that can halt production and expose sensitive data. Merck’s 2017 NotPetya attack serves as a cautionary tale. The attack caused $870 million in damages and showed how IT/OT integration made manufacturing systems vulnerable targets.
Ransomware and Supply Chain Attack Risks
Studies show that 10% of pharmaceutical companies face high risks from ransomware attacks. Medium-sized companies remain the most vulnerable. The impact goes beyond money losses – downtime in this vital sector puts patient care and drug supplies at risk. Supply chains create more ways for attackers to get in. The data shows 63% of pharma sector breaches happen due to weak access controls. Last year, 45% of organizations reported data breaches through third parties.
Security Patch Management Across Distributed Systems
Industrial control systems have become more vulnerable since moving from proprietary platforms to commercial off-the-shelf equipment. Pharma facilities’ patch management brings tough questions:
- Which systems need specific patches?
- What’s the right time to install updates that need system reboots?
- How can we customize patches for different systems?
Eli Lilly’s case with 15 distributed control systems proves these challenges. Their automated patch management saved days of work for each update. The system delivered correct updates to the right machines and reduced human error.
HIPAA and GDPR Data Protection Requirements
Pharma companies must follow strict data protection rules. HIPAA Security Rule requires companies to use “reasonable and appropriate administrative, physical, and technical safeguards” to protect electronic health data. Companies need to keep data secure, accurate, and available while protecting against predicted threats.
European operations must meet GDPR standards through technical and organizational measures (TOMs) to protect personal data. Breaking these rules can lead to fines up to €20 million or 4% of annual global turnover. This shows why strong data protection matters in pharma IT systems.
AI-Driven IT Operations in Top-Performing Facilities
High-performing pharmaceutical facilities are turning to AI to streamline IT operations, boost system reliability, and reduce manual workloads. These advanced tools address key operational challenges while helping companies maintain compliance.
Here are some of the most effective AI-driven solutions in use today:
- Predictive analytics for system downtime prevention: AI-powered maintenance systems analyze both historical trends and real-time sensor data to identify potential equipment failures before they occur. For example, Pfizer replaced its traditional preventative maintenance approach with predictive models using Proficy Historian and industrial analytics. The shift led to reduced downtime, improved efficiency, and increased yield. The company also reported a 20 to 50 percent reduction in maintenance planning time and a 10 to 20 percent boost in equipment uptime.
- AI copilots for ticket categorization and resolution: AI copilots transform IT support by automating ticket triage, routing, and classification. These tools allow support teams to concentrate on more complex problems. They also generate concise case summaries, assess customer sentiment, write resolution notes, and search knowledge bases to provide accurate responses in natural language.
- Agentic AI for device monitoring and patch scheduling: Agentic AI handles system monitoring and patch deployment autonomously. It reviews device configurations, prioritizes patches based on risk, and anticipates potential vulnerabilities. These machine learning systems actively monitor pharma IT environments and begin patching as needed, which minimizes manual effort, limits human error, and improves overall security.
Conclusion
Pharmaceutical companies face mounting pressure to modernize their IT infrastructure while maintaining strict compliance, security, and operational efficiency. The risks of relying on outdated systems are no longer theoretical. Real-world cases have shown how quickly vulnerabilities can disrupt production, expose sensitive data, and jeopardize patient safety.
As the industry moves toward more connected and intelligent systems, forward-thinking organizations are already investing in AI-driven solutions, robust cybersecurity practices, and better integration across departments.
Modernizing pharma IT is no longer a choice. It is a business-critical strategy that separates reactive operations from those that lead the way.
Image by freepik from freepik
The editorial staff of Medical News Bulletin had no role in the preparation of this post. The views and opinions expressed in this post are those of the advertiser and do not reflect those of Medical News Bulletin. Medical News Bulletin does not accept liability for any loss or damages caused by the use of any products or services, nor do we endorse any products, services, or links in our Sponsored Articles.
Security gaps in pharmaceutical IT systems can lead to serious consequences. One of the most damaging cyberattacks in the industry struck Merck & Co. in 2017, when malware disabled 30,000 computers globally and halted production, resulting in $870 million in losses. In such a highly regulated field, maintaining a resilient IT infrastructure is not just beneficial but essential for survival.
Despite the growing urgency, AI-powered enterprise software is still rare in the sector, with adoption below 1 percent in 2024. However, experts expect this figure to rise to 33 percent by 2028, highlighting the fast pace of digital transformation in pharma IT. At the same time, unresolved production issues continue to cause delays, compliance failures, and unplanned costs.
This article explores how top pharmaceutical facilities are modernizing their IT systems to meet these challenges.
Regulatory Compliance in Pharma IT Systems
Pharmaceutical companies must follow strict regulatory requirements for their IT systems in global markets. These regulations are not optional. They are the foundations of pharma IT operations and directly affect patient safety, data integrity, and business continuity.
FDA and EMA Requirements for IT Infrastructure
The FDA and European Medicines Agency set detailed frameworks that govern pharma IT infrastructure. The FDA’s 21 CFR Part 11, to name just one example, lists criteria for electronic records and signatures to ensure they’re as trustworthy as paper records. This rule covers the whole computerized system, including hardware, software, peripheral devices, personnel, and documentation.
The EMA released its “Guideline on computerized systems and electronic data in clinical trials” that took effect from September 2023. This guideline requires biotech and pharmaceutical companies to verify compliance when their staff access electronic data. It focuses on data integrity through ALCOA++ principles and tackles modern challenges like:
- Cloud solutions implementation
- Data migration processes
- Electronic signatures replacing wet ink signatures
- AI integration in clinical trials
IT infrastructure qualification has become crucial because infrastructure elements can affect regulatory data integrity, availability, and confidentiality. ISPE GAMP guidance states that GxP applications’ validated status might be compromised if the IT infrastructure isn’t in a proven state of control.
HIPAA Compliance in Clinical Data Management
Pharma IT solutions must also protect patient data through HIPAA compliance. This law sets national standards for electronic healthcare transactions and tackles vulnerabilities in clinical data management.
HIPAA breaches have affected over 176 million patients in the United States. Most incidents stem from employee negligence rather than external hacking. The HIPAA Security Rule requires three key safeguard categories:
- Administrative safeguards: Policies, procedures, and training programs that ensure regulation awareness
- Physical safeguards: Access controls that protect systems with patient data
- Technical safeguards: Technologies that protect electronic health records
HIPAA also requires pharmaceutical companies to implement risk assessment processes. These processes assess potential threats to protected health information’s confidentiality, integrity, and availability. This risk-based approach helps companies choose security measures that match their size, capabilities, and specific threats.
Overcoming Legacy Infrastructure Limitations
Many pharmaceutical companies are still held back by outdated infrastructure, despite years of investment in their facilities. Aging IT and OT systems continue to slow innovation, limit efficiency, and create operational bottlenecks.
These are some of the most common issues caused by legacy systems:
- Limited remote management capabilities: Older infrastructure often lacks remote access features, forcing IT teams to be on-site for troubleshooting and maintenance. This became a serious concern during the COVID-19 pandemic, which accelerated digital transformation timelines by nearly a decade. Pharma IT environments are spread across offices, labs, clinical sites, and production plants, making centralized management difficult and increasing the risk of inconsistent standards and security practices.
- Lack of visibility in outdated manufacturing systems: Legacy systems often operate in silos, with little to no integration across departments. Outdated ERP platforms cannot track profitability or manufacturing costs in real time, leading to poor coordination and overstocked inventory. Adopting modern OEE software manufacturing solutions can help close these visibility gaps by providing real-time performance metrics and actionable insights across production lines.
- Challenges in integrating modern IT solutions: Siloed databases and fragmented systems make interoperability difficult. These barriers slow clinical trials, raise maintenance costs, and block access to newer technologies like AI and advanced analytics. While 40 to 50 percent of leading pharma firms have invested in modernizing IT applications, many still struggle to see measurable returns. Integration middleware can help connect old systems with new ones, but a piecemeal approach to upgrades often leaves critical gaps in the data pipeline.
Cybersecurity and Data Protection in Pharma IT
Pharmaceutical operations face growing cybersecurity threats that can halt production and expose sensitive data. Merck’s 2017 NotPetya attack serves as a cautionary tale. The attack caused $870 million in damages and showed how IT/OT integration made manufacturing systems vulnerable targets.
Ransomware and Supply Chain Attack Risks
Studies show that 10% of pharmaceutical companies face high risks from ransomware attacks. Medium-sized companies remain the most vulnerable. The impact goes beyond money losses – downtime in this vital sector puts patient care and drug supplies at risk. Supply chains create more ways for attackers to get in. The data shows 63% of pharma sector breaches happen due to weak access controls. Last year, 45% of organizations reported data breaches through third parties.
Security Patch Management Across Distributed Systems
Industrial control systems have become more vulnerable since moving from proprietary platforms to commercial off-the-shelf equipment. Pharma facilities’ patch management brings tough questions:
- Which systems need specific patches?
- What’s the right time to install updates that need system reboots?
- How can we customize patches for different systems?
Eli Lilly’s case with 15 distributed control systems proves these challenges. Their automated patch management saved days of work for each update. The system delivered correct updates to the right machines and reduced human error.
HIPAA and GDPR Data Protection Requirements
Pharma companies must follow strict data protection rules. HIPAA Security Rule requires companies to use “reasonable and appropriate administrative, physical, and technical safeguards” to protect electronic health data. Companies need to keep data secure, accurate, and available while protecting against predicted threats.
European operations must meet GDPR standards through technical and organizational measures (TOMs) to protect personal data. Breaking these rules can lead to fines up to €20 million or 4% of annual global turnover. This shows why strong data protection matters in pharma IT systems.
AI-Driven IT Operations in Top-Performing Facilities
High-performing pharmaceutical facilities are turning to AI to streamline IT operations, boost system reliability, and reduce manual workloads. These advanced tools address key operational challenges while helping companies maintain compliance.
Here are some of the most effective AI-driven solutions in use today:
- Predictive analytics for system downtime prevention: AI-powered maintenance systems analyze both historical trends and real-time sensor data to identify potential equipment failures before they occur. For example, Pfizer replaced its traditional preventative maintenance approach with predictive models using Proficy Historian and industrial analytics. The shift led to reduced downtime, improved efficiency, and increased yield. The company also reported a 20 to 50 percent reduction in maintenance planning time and a 10 to 20 percent boost in equipment uptime.
- AI copilots for ticket categorization and resolution: AI copilots transform IT support by automating ticket triage, routing, and classification. These tools allow support teams to concentrate on more complex problems. They also generate concise case summaries, assess customer sentiment, write resolution notes, and search knowledge bases to provide accurate responses in natural language.
- Agentic AI for device monitoring and patch scheduling: Agentic AI handles system monitoring and patch deployment autonomously. It reviews device configurations, prioritizes patches based on risk, and anticipates potential vulnerabilities. These machine learning systems actively monitor pharma IT environments and begin patching as needed, which minimizes manual effort, limits human error, and improves overall security.
Conclusion
Pharmaceutical companies face mounting pressure to modernize their IT infrastructure while maintaining strict compliance, security, and operational efficiency. The risks of relying on outdated systems are no longer theoretical. Real-world cases have shown how quickly vulnerabilities can disrupt production, expose sensitive data, and jeopardize patient safety.
As the industry moves toward more connected and intelligent systems, forward-thinking organizations are already investing in AI-driven solutions, robust cybersecurity practices, and better integration across departments.
Modernizing pharma IT is no longer a choice. It is a business-critical strategy that separates reactive operations from those that lead the way.
Image by freepik from freepik
The editorial staff of Medical News Bulletin had no role in the preparation of this post. The views and opinions expressed in this post are those of the advertiser and do not reflect those of Medical News Bulletin. Medical News Bulletin does not accept liability for any loss or damages caused by the use of any products or services, nor do we endorse any products, services, or links in our Sponsored Articles.