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From groundbreaking research to essential drug manufacturing, today’s pharmaceutical work requires a robust IT infrastructure. Yet as digital transformation accelerates across pharma, IT teams face a critical challenge: Modernizing systems at scale while hindered by strict regulations, legacy systems, and complex workflows.
Pharmaceutical IT teams must navigate a complex regulatory landscape that includes FDA and GMP (Good Manufacturing Practice) requirements for drug manufacturing, and in some cases, HIPAA regulations. The challenge is balancing compliance with efficiency, security, and scalability.
This blog explores the barriers to IT modernization in pharmaceuticals and how IT teams can overcome them to improve productivity and security while staying compliant.
The unique challenges of pharma IT modernization
While digital transformation is reshaping many industries, pharmaceutical IT services face distinct obstacles, including:
1. Compliance and regulatory constraints
Pharmaceutical companies operate under strict regulatory requirements set by bodies like the FDA (Food and Drug Administration—governing pharmaceutical manufacturing and data integrity in the US) and EMA (European Medicines Agency—overseeing pharmaceutical regulation, drug approvals, and data integrity across the European Union).
Additionally, companies involved in clinical trials or handling patient data must comply with HIPAA regulations to protect sensitive health information. These overlapping regulatory requirements make system changes complex and time-consuming, as IT teams must ensure that new technologies meet stringent compliance standards.
2. Legacy systems hold back efficiency
Many pharmaceutical companies still rely on aging IT infrastructure, making it difficult to integrate tools such as IT automation, AI, and predictive analytics. Legacy systems often:
- Lack remote management capabilities, requiring IT teams to be physically present for troubleshooting
- Are incompatible with modern cybersecurity measures, increasing vulnerability to security threats
- Drive up operational costs due to inefficiencies and high maintenance demands
This reliance on outdated technology can hinder operational efficiency, limit scalability, and slow down IT’s ability to support business growth or deal with sudden changes. The COVID-19 pandemic was a sector-wide wakeup call for the pharmaceutical industry, but not every company has risen to the challenge equally.
Manoj Raghunandan president, global self-care and consumer experience at Johnson & Johnson said in 2021:
“Digital innovation has been accelerated by 10 years by what has happened over the course of the last 18 months.”
Manoj Raghunandan
3. Managing IT across multiple locations
The IT landscape in the pharmaceutical industry is often decentralized, with teams supporting corporate offices, R&D labs, clinical trial sites, and manufacturing plants. Each environment has unique IT requirements, security protocols, and compliance needs. This complexity makes it challenging to:
- Maintain consistent IT standards and security policies across all locations
- Ensure real-time visibility and control over devices and systems
- Support remote work and collaboration effectively, especially in multinational organizations
4. Growing cybersecurity risks in pharma IT
💡 Did you know ?
The most damaging known attack in the sector to date is the 2017 malware attack on Merck & Co.’s, taking down 30,000 computers globally and grinding production to a halt, with the damages estimated at $870 million.
Pharmaceutical companies are prime targets for data breaches, phishing and social engineering, and cyber espionage due to the sensitive nature of their data, including intellectual property, proprietary drug research, and clinical trial information. The rise of ransomware, insider threats, and supply chain attacks has elevated the importance of strong cybersecurity measures. Key challenges include:
- Managing security across diverse IT environments
- Keeping up with the volume of security patches needed to protect against emerging threats
- Ensuring regulatory compliance related to data protection, particularly for HIPAA-covered data and GDPR in the EU
- Security across the supply chain
5. Leveraging AI for smarter, faster IT management
💡 Did you know ?
While less than 1% of enterprise software applications used Agentic AI in 2024, that number is expected to rise to 33% by 2028, enabling 15% of day-to-day work decisions to be made by autonomous AI. Businesses are focusing their efforts mostly on IT, data processing and analytics, and code development and testing.
AI is transforming the way pharmaceutical IT teams manage complex environments by enabling predictive analytics, intelligent automation, and data-driven decision-making. AI-powered IT management tools can:
- Proactively identify potential issues before they escalate, reducing downtime and improving system reliability
- Optimize resource allocation by analyzing patterns in IT performance and recommending efficiency improvements
- Enhance security through intelligent threat detection, automatically flagging suspicious activities and potential vulnerabilities
- Streamline IT operations by automating repetitive tasks like ticket categorization, device monitoring, and patch scheduling
- Upskill junior techs
Because AI is an emerging technology, it’s important to verify vendors thoroughly to ensure they are safeguarding data and following responsible AI principles.
5. Simplified compliance through better reporting and visibility
Meeting regulatory requirements can be resource-intensive, but IT solutions with robust reporting capabilities can streamline the process. Features like audit trails, compliance dashboards, and automated reporting help:
- Track system changes and user activity for regulatory audits
- Demonstrate adherence to FDA, GMP, HIPAA, and other standards
- Reduce the administrative burden on IT teams by automating compliance documentation
The future of pharma IT is proactive and automated
As the pharmaceutical industry continues to evolve, IT modernization is no longer optional—it’s a necessity. By addressing key challenges like regulatory compliance, legacy systems, decentralized operations, and cybersecurity risks, pharma IT teams can build a more resilient, efficient, and secure IT environment.
Modern IT management solutions play a critical role in this transformation. Through automation, centralized management, proactive security, AI, and compliance-ready reporting, pharmaceutical companies can future-proof their IT operations while supporting innovation and growth.
Atera’s all-in-one IT management platform is uniquely positioned to support pharmaceutical IT teams in this journey. With a deep foundation in Agentic AI, Atera offers a digital workforce of AI agents that proactively and autonomously support your entire IT operations. Its platform consolidates remote monitoring and management (RMM), helpdesk, ticketing, and automation, providing complete visibility across multiple locations. This enables IT teams to efficiently manage devices, monitor performance, and troubleshoot issues—whether in corporate offices, manufacturing plants, or R&D labs—while ensuring that IT environments remain secure, compliant, and efficient.
Additionally, Atera’s Agenric AI-powered automation streamlines routine IT tasks, from ticket management to device monitoring, reducing manual workloads and freeing up IT staff to focus on strategic initiatives. Its robust reporting features support compliance efforts with detailed audit logs and system activity tracking, making it easier to meet regulatory requirements like FDA, GMP, HIPAA, and EMA standards. Trusted by over 12,000 customers in 120+ countries, Atera offers a scalable, cost-effective solution designed to keep IT operations agile, secure, and compliant, helping pharmaceutical companies drive sustainable growth and maximize organizational efficiency.
Are you ready to modernize your IT infrastructure? Discover how intelligent IT management solutions can help your pharmaceutical organization overcome today’s challenges and prepare for the future by scheduling a demo with our experts.
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