Why Cyber Risk Is Becoming an Operational Issue for Pharmaceutical Manufacturers

In pharmaceutical manufacturing, cybersecurity has become more than an IT and compliance concern. Because production relies on global supply chains and interconnected vendors, a single cyberattack can cause critical operational issues.

In May 2026, West Pharmaceutical Services reported a ransomware attack that impacted its shipping and manufacturing processes. After detecting the attack on May 4, the firm didn't confirm it was fully operational until May 20. It is a stark example of how even well-established manufacturers are at risk from hackers.

Although the firm said the attack would not affect its 2026 financial forecast, it still left a series of vital processes temporarily inoperable. For many pharmaceutical businesses, this would translate into serious financial loss.

IBM’s 2026 Cost of a Data Breach research shows that the average cost of a pharmaceutical data breach rose from $4.61 million to $5.25 million in a year. Cyber incidents are causing manufacturers to miss critical schedules, hold batches, and ship late, all of which drive costs higher.

To better prepare for these threats, operations managers must carefully consider secure production planning, batch record and quality data access, vendor access rights, and recovery procedures.

When a Compromised Account Disrupts Production Planning

Attackers who gain access through stolen credentials, phishing, or misused staff accounts can bring production planning to a halt. For example, if an attacker gains access to planning boards and inventory tracking using stolen credentials, plant managers cannot safely or reliably sequence materials or schedule logistics.

Phishing, a confidence trick attackers use to deceive employees into giving access to sensitive information and systems, remains the most prevalent attack vector across industries. Credential harvesting features heavily in phishing trends and gives attackers a direct route into planning systems.

Containing threats can also cause a planning lockdown until conditions are confirmed safe. In West Pharmaceutical’s case, the company restricted access to its enterprise systems. This measure, while effective, may have left planners without access to tools until the ransomware threat was neutralized.

Useful safeguards include:

Keeping offline backups of schedules and bills of materials
Regularly rehearsing manual fallbacks to ensure planning can continue
Enforcing multi-factor authentication (MFA) and least-privilege access so only authorized users reach planning systems

When Batch Records and Quality Data Become Unavailable

Maintaining data integrity and access is vital to operational stability. Without access to quality data and complete batch records, manufacturers cannot release batches or dispatch product until threats are contained. If ransomware fully encrypts batch record systems, for example, finished product sits in quarantine even if it is not physically affected.

Regulations also set data integrity standards. Under US regulation 21 CFR § 211.68, all backup data must be exact, complete, and secure from alteration, erasure, and loss. If ransomware encrypts or corrupts backup data, an operational outage soon becomes a compliance concern.

Safeguards include keeping paper-based batch records as a fallback and regularly testing offline backups; however, paper records must still meet regulatory requirements and quality standards.

Regardless of the protections and plans in place, data stolen during an attack could create further regulatory and legal risks. Manufacturers should therefore prepare for the potential fallout with communication and notification plans.

Where Vendor Access Affects Manufacturing Operations

For plant systems to run smoothly, connections to third-party vendors are frequently required. For example, vendors such as equipment manufacturers and cloud quality-system providers can remotely access manufacturing systems for maintenance, upgrades, and ongoing support.

While necessary, these remote routes expand the attack surface, as each new vendor adds to it. An attacker targeting a vendor can exploit its perimeter and gain access to partners if the vendor’s cybersecurity processes are not robust enough.

Even when attackers gain access via such vendors, the manufacturer remains accountable. While support and supply may be outsourced, responsibility for data integrity and secure connections is not. In practice, plant managers should keep a clear, updated map of vendors, their access points, and their permissions. It is wise to log individual vendor sessions and grant system access only when specifically required.

Managers should also include vendor access and security expectations in contracts, and request details of vendor continuity planning to support risk assessments.

Restoring Systems Without Rushing Quality Decisions

Bringing manufacturing systems back online and fully operational after a cyberattack requires careful reinstatement of tools and sites. While it makes sense operationally to get lines running again, manufacturing environments cannot simply be “switched back on” without system validation and documentation.

Best practices for ensuring data and systems are safe to restore include risk assessments and thorough verification tests. Analyzing data and systems post-attack helps confirm records are complete and reliable again and that no audit gaps remain.

What’s more, managers should take time to analyze all batches that may have been impacted around the time of the attack. Releasing batches without these checks risks product quality, recalls, and patient safety, in addition to extra downtime.

Bouncing back from any cyberattack will require open communication and clear delegation of duties and accountability across several departments. For example, QA, operations, and IT each play different roles to ensure manufacturing can return to its previous operational standard. QA decides if the release should go ahead, operations puts together the restart, and IT brings systems back online.

A practical way to support open communication and pre-agreed decision criteria is to run tabletop exercises between all three departments. This helps to show how teams would react in live situations, should they need to bring systems back online after an attack.

Pharmaceutical systems will always face some form of cyber threat. However, what can change is how managers and teams approach operational risk, cybersecurity standards, and recovery plans. Prioritizing cybersecurity is essential, given the negative impact on operations and product quality should it be neglected.

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