How to meet critical compliance regulations in pharmaceutical manufacturing

Pharmaceutical regulation relies on three core pillars: Maximum system availability, trustworthy data and rapid recoverability. With the right strategy, manufacturers can uphold them all.

Operational technology (OT) systems such as SCADA, manufacturing execution systems, cleanroom controls, environmental monitors and laboratory automation are essential for maintaining validated, compliant and uninterrupted production. When those systems fail, downtime can result in enormous financial costs. Outages can also lead to significant compliance penalties, including, in severe cases, potential criminal liability.

In order to stay up and running, and maintain compliance, modern pharmaceutical manufacturers have to align with multiple regulatory frameworks, including GxP, FDA 21 CFR Part 11 and the EU’s NIS 2 Directive. Those regulations differ in scope, but they share common expectations around protecting critical systems, ensuring data integrity and maintaining recoverability.

For pharmaceutical manufacturers, compliance is inseparable from maintaining continuous, validated operations.

Regulators understand that manufacturing interruptions have causes that go beyond equipment failure or human error. Cyberattacks, ransomware, supply chain compromises and natural disasters all threaten production continuity, and therefore product quality and patient safety.

Pharmaceutical OT environments present unique challenges because many systems are:

• Running on legacy operating systems that manufacturers cannot easily update without revalidation.
• Difficult or impossible to secure with modern endpoint detection tools due to vendor restrictions or legacy architectures.
• Located in remote, air-gapped or highly segmented networks often without on-site IT support.
• Dependent on highly specialized validated applications that cannot tolerate downtime, reinstallation or unexpected configuration changes.

These factors make recovery readiness a critical regulatory and operational control. Older OT systems eventually lose vendor support, forcing teams into manual, error-prone backup processes that require planned downtime and introduces risk.

With a strong cyber resilience strategy, manufacturers can bridge the gap between operational uptime and regulatory compliance. To accomplish that goal, they need to be intimately familiar with key compliance requirements.

These frameworks originate from different regions and regulatory bodies, but they share several core compliance principles:

• GxP emphasizes that regulated data must be accurate, complete and protected throughout its lifecycle.
• FDA 21 CFR Part 11 focuses on ensuring electronic records and signatures are trustworthy and equivalent to paper records, backed by validated systems.
• NIS 2 requires organizations to manage cybersecurity risk and ensure secure handling of critical information systems.

In all cases, manufacturers must demonstrate that records are protected from loss, alteration or destruction during an incident.

Production uptime is closely linked to patient safety, product quality and regulatory obligations. Downtime can result in unfulfilled orders, damaged reputation and penalties for failure to meet resilience requirements. Reliable data backup and fast recovery are foundational controls for ensuring continuity.

Each regulation requires that organizations demonstrate:

• Documented processes.
• Controlled access to systems.
• Reliable recovery procedures.
• Evidence of compliance during inspections or audits.

Cyber resilience solutions must support these audit requirements with automated processes, detailed logging and secure, testable recovery.

Understanding the differences among compliance requirements helps manufacturers align the right controls with the right regulatory drivers.

GxP is a broad umbrella covering Good Manufacturing Practice, Good Laboratory Practice and other concepts. It applies globally across regulated life sciences operations. Its primary concerns are product quality, patient safety, validated processes and data integrity across manufacturing, laboratory and distribution systems.

Part 11 is a U.S. regulation governing the use of electronic systems for regulated documentation. It requires controls such as:

• Secure record retention
• Audit trails
• Access management

• Validation of electronic systems

Backup and recovery are critical to ensuring records remain available and uncorrupted.

NIS 2 is a European directive focused on strengthening cybersecurity for essential and important entities, including healthcare and pharmaceutical supply chains.

It places heavy emphasis on:

• Incident response
• Business continuity
• Cyber risk governance
• Reporting obligations

NIS 2 elevates cyber resilience to an executive‑level obligation by requiring clear accountability at the leadership level.

Acronis Cyber Protect for OT enables protection of pharmaceutical manufacturing environments where uptime, legacy compatibility and recoverability are essential. Manufacturers can uphold the three pillars of pharmaceutical regulation and stay in compliance with critical regulations by adopting Acronis solutions specifically designed for highly regulated industries.

Backup without disrupting production: Acronis provides an on-premises backup management console that allows backup agents to run without taking OT systems offline. This supports continuous operations while maintaining protection.

Protection for legacy systems common in pharmaceutical OT: Many pharmaceutical OT systems still operate on older platforms. Acronis protects operating systems from the Windows XP era through to modern environments, ensuring recovery even when other vendors no longer support those systems. Bare‑metal recovery enables restoration to new hardware by automatically installing required drivers, ensuring systems and applications continue to operate as expected.

Facilities: Pharmaceutical manufacturing sites are often air-gapped and lack local IT support. Acronis One‑Click Recovery enables local personnel — even without IT expertise — to restore a failed OT system in minutes from local backup or the Acronis Cloud. This capability supports business continuity obligations under NIS 2 and helps maintain uptime across regulated production environments.

Fast, automated recovery across OT environments: Automated backup execution reduces overhead on OT systems and helps standardize protection plans across sites. This is essential for meeting resilience expectations under NIS 2 and ensuring validated recovery under GxP, 21 CFR Part 11 and NIS 2.

Integrated cybersecurity to strengthen resilience: Manufacturers can apply natively integrated anti‑malware and anti‑ransomware protection through a single lightweight Acronis agent to secure OT systems against modern threats while also supporting compliance readiness.

Cyber resilience requires not only strong recovery capabilities but also confidence in the security of the software supply chain. Acronis achieved IEC 62443-4-1 certification by demonstrating secure software development practices aligned with industrial cybersecurity standards.

For pharmaceutical manufacturers operating critical OT environments, this certification provides assurance that Acronis resilience controls are built on a foundation of secure engineering practices.

GxP, FDA 21 CFR Part 11 and NIS 2 all demand that pharmaceutical manufacturers maintain:

• Data integrity.
• Operational availability.
• Rapid recoverability.
• Documented controls and audit readiness.

Acronis Cyber Protect for OT enables manufacturers to meet these requirements with purpose‑built backup and recovery for legacy OT, air‑gapped environments and high‑uptime production.

Cyber resilience is now inseparable from regulatory compliance in pharmaceutical and medical device manufacturing. Learn how Acronis helps protect critical OT systems and support global compliance requirements. Explore the Acronis Cyber Protect for OT biopharma backup solution.