21 CFR Part 11 Compliance and Cybersecurity: Why Pharma Companies Need Penetration Testing

Summary

• The pharmaceutical industry is one of the most targeted verticals for ransomware with 191 attacks in 2025 alone.
• 21 CFR Part 11 requires validated, secure, and trustworthy electronic records and e-signatures.
• Penetration testing supports system validation, which is a core Part 11 requirement.
• Pentests can assess audit trail integrity, e-signature security, and access controls.
• Continuous penetration testing helps pharma firms demonstrate ongoing security maturity to regulators.

Key Terms

• 21 CFR Part 11: FDA regulation governing the use of electronic records and e-signatures in regulated industries.
• Audit Trail: Tamper-resistant, time-stamped logs of actions taken on electronic records.
• Electronic Records (ER): Digital documents that must meet Part 11 security and integrity standards.
• Electronic Signatures (ES): Digital equivalents of handwritten signatures; must be legally defensible under Part 11.
• IQ/OQ/PQ: Installation Qualification, Operational Qualification, and Performance Qualification, encompassing the three phases of the Part 11 validation process.
• System Validation: The process of confirming electronic systems function reliably, accurately, and securely throughout their lifecycle.

How Penetration Testing Strengthens Part 11 System Validation

In August 2025, Inotiv, an Indiana-based pharmaceutical research company, lost 176 GB of sensitive data following a ransomware attack.¹ This incident was only one among hundreds of ransomware attacks, 191 in total, targeting pharma firms in 2025.² Moreover, the frequency of such attacks increased by 25% from 2024 to 2025, indicating the high and burgeoning risk of attack to the pharma sector.²

Pharmaceutical firms create, process, and store massive quantities of valuable data, making them attractive targets for cyberattacks and data breaches. Malicious actors steal and misuse this data for identity theft, insurance fraud, and other crimes. They also demand huge ransoms from the victims in exchange for returning the data. Such breaches may lead to financial losses for affected companies. These losses can be substantial, as the healthcare industry carries the highest average breach cost of any sector at $7.42 million in 2025.³

The FDA’s 21 CFR Part 11 regulation aims to mitigate cyber threats in FDA-regulated industries like pharmaceuticals. This regulation requires organizations in these industries to validate their electronic systems to ensure that they are functioning as intended and maintaining data security, confidentiality, and integrity.

Continuous penetration testing provides a reliable and repeatable way to perform such validations and maintain Part 11 compliance. Pentesting also empowers pharma companies to demonstrate their commitment to proactive, long-term security of electronic systems, and thus earn the trust of regulators and customers.

What is 21 CFR Part 11? What Pharma Companies Should Know

The U.S Food and Drug Administration (FDA) introduced 21 Code of Federal Regulations (CFR) Part 11, also known simply as Part 11, in 1997. This regulation establishes the criteria that determine whether the electronic records and electronic signatures (e-signatures) used and maintained by pharma (and other healthcare) firms are:

• Secure
• Trustworthy
• Validated
• Reliable
• Traceable

Part 11 criteria also determine if e-signatures are legally equivalent to paper records and handwritten (“wet-ink”) signatures.

This regulation requires pharma companies to implement robust controls to maintain data security and integrity in electronic systems. With these controls in place, they can safely use the systems, access, store, and sign electronic data, and prevent unauthorized data modification and losses.

The System Validation Requirement in 21 CFR Part 11

System validation is a critical requirement for achieving Part 11 compliance. Pharma companies must validate their electronic systems to ensure that they:

• Function consistently, reliably, and accurately under expected conditions
• Are tamper-resistant throughout their lifecycle
• Maintain data integrity
• Can discern invalid or altered records

Part 11 also requires firms to document their validation process. Auditors frequently ask for documents such as the validation report, user requirement specifications (URS), functional specifications (FS), and documentation resulting from the Installation Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ) validation phases. Pharma companies are expected to produce these documents as needed. Missing or incomplete documentation can hinder the compliance effort and may even result in failure.

Pentesting services simplify system validation and eases Part 11 compliance.

Fulfilling the System Validation Requirement with Penetration Testing

Continuous, comprehensive pentesting is not a mandatory requirement to comply with 21 CFR Part 11. However, by implementing Penetration Testing as a Service (PTaaS), pharma companies can garner numerous benefits. These include:

Proactively Identify Security Threats to Electronic Records

A well-planned pentesting exercise enables pharma companies to validate and prove that their systems are secure against real-world attacks. During the pentest, testers attempt to access restricted records, bypass authentication mechanisms, and escalate privileges. They may also assess SQL injection vulnerabilities, manipulate APIs, and try to directly access databases.

Through these actions, they can verify if security controls work effectively under real-world attack conditions to prevent unauthorized system use and ensure/maintain data integrity.

Proactively Identify Security Threats to Electronic Signatures

Pentesters employ numerous methods to test and validate e-signatures, and prove that they are equivalent to handwritten signatures, are legally defensible, and cannot be used to falsify electronic records. The testers may try to steal credentials, hijack user sessions, inject approval actions, replay authentication tokens, or bypass re-authentication controls.

If any of these actions result in the reuse, compromise, or forgery of an e-signature, it indicates compliance risk. Security teams can then act promptly to remediate the risk and safeguard e-signatures from compromise.

Validate the Integrity of Audit Trails

Part 11 mandates that healthcare organizations create secure, time-stamped, computer-generated audit trails whenever an electronic record is created, modified, or deleted. They must also retain audit trail documentation for a suitable period. Pentesting supports these requirements.

Pentesters can evaluate whether audit logs can be altered or deleted, if timestamps can be manipulated, and if unauthorized parties could potentially disable logging. If the testers discover that audit trails are tamperable, manipulable, or modifiable, it may indicate that the system may not satisfy Part 11 expectations and warrant remediation.

Demonstrate Enhanced Security Maturity

Continuous penetration testing enables pharma companies to demonstrate ongoing security validation, that they perform risk-based security assessments, and have implemented strong measures to manage risk. These activities signal that the firm proactively and consistently protects electronic systems and has a high degree of security maturity and cyber resilience.

Reliable System Validation and Faster Part 21 CFR 11 Compliance with BreachLock Penetration Testing

Accelerate your 21 CFR Part 11 compliance with BreachLock penetration testing services. Our continuous and customized PTaaS will help your pharma company to fulfill the requirements of Part 11, particularly around system validation.

Take advantage of our pentesting expertise and the BreachLock Unified Platform to identify and eliminate the most exploitable points of interest by real-world attackers. Our expert-led, agentic AI-accelerated PTaaS will also ensure that your security controls remain effective and consistently pass the Part 11 stress test.

Proactive validation for Part 11 compliance starts with BreachLock. Get started today by telling us about your testing requirements.

References

1. The HIPAA Journal (December 2025). Pharmaceutical Firm Inotiv Discloses Ransomware Attack and Data Breach. https://www.hipaajournal.com/inotiv-data-breach-ransomware-attack/

2. Comparitech (January 2026). Healthcare Ransomware Roundup: 2025 stats on attacks, ransoms, and data breaches. https://www.comparitech.com/news/healthcare-ransomware-roundup-2025-stats-on-attacks-ransoms-and-data-breaches

3. IBM (2025). Cost of a Data Breach Report 2025. https://www.ibm.com/reports/data-breach

Author

BreachLock Labs