How pharma organizations can strengthen resilience with immutable archives and smart cybersecurity strategies

Logo_TileCyberattacks continue to rise in frequency, scale, and sophistication — and the pharmaceutical industry remains one of the most attractive targets. In the fourth episode of DatenDokuDigital – The Pharma Archive Podcast by biomedion GmbH biomedion’s Julian Weber and Dr. Philipp Krubasik discuss “Ransomware and Cybersecurity in the Pharma Sector” together with guest expert Lukas Schäfer from iTernity. The episode delivers a clear message: ransomware is not only a technical problem — it is an existential business risk that threatens data integrity, operational continuity, and regulatory compliance.
This article summarises the expert discussion, highlights essential prevention strategies, and shows how secure long-term archiving — including solutions such as biomedion Watcher 4.0 — forms a critical pillar of cyber-resilience in modern GxP environments.

Why Cybersecurity Has Become a Critical Risk in Pharma

Ransomware Attacks Are Increasing — and Evolving

According to Lukas Schäfer, ransomware is no longer limited to simple file encryption. Modern attacks often follow multi-stage patterns:

•    Infiltration through phishing, social engineering, or supply-chain compromises
•    Data exfiltration
•    Encryption of critical systems
•    Multi-layer extortion (e.g., ransom + threat of data release)

The podcast highlights QR-code-phishing, an emerging trend where attackers abuse QR codes to bypass common MFA mechanisms.

Sensitive Data Makes Pharma a Prime Target

Pharmaceutical companies manage:

•    clinical data
•    manufacturing batch records
•    research IP
•    regulatory documentation
•    GxP-relevant lab data

This information has high black-market value and is essential for patient safety, compliance, and business continuity — making it extremely lucrative for attackers.

The Real Damage: Downtime, Not the Ransom

Why operational interruptions pose the greatest financial and compliance risks in pharma

One of the podcast’s most striking insights:  “A ransom demand is no longer the biggest financial risk.”
Based on current industry data discussed in the episode:

•    Average downtime after a cyberattack: 20 days
•    The cost of 20 days of halted lab operations far exceeds typical ransom demands
•    Disrupted trials, delayed submissions, and halted production create ripple effects across the entire organisation

This is why efficient, tested emergency plans and resilient data recovery capabilities are mission-critical for any pharma or life-science organisation.

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Key Strategies Discussed in the Podcast

1. The Importance of Immutable Backups

Immutable (WORM-compliant) data storage prevents manipulation or deletion — even by internal administrators or malicious actors.

Lukas Schäfer emphasises that immutable storage is essential because once ransomware hits, the integrity of all mutable storage becomes questionable.

biomedion Watcher 4.0 and iTernity storage technologies both support this principle, making them powerful tools for GxP-ready cyber-resilience.

2. Applying the 3-2-1-1-0 Backup Strategy

The podcast explains the gold standard for secure backups:

3 copies of your data
2 different storage types
1 off-site copy
1 offline or immutable copy
0 backup errors verified through regular integrity checks

This strategy dramatically increases the likelihood of a fast and secure recovery.

3. Understanding NIST 2 and Modern Cyber Regulations

The hosts and guest explain how NIST 2 provides a structured framework for risk assessment, incident response, and preventive cybersecurity.

For pharma companies operating under GxP conditions, these guidelines align well with regulatory expectations for:

•    data integrity
•    audit trails
•    continuity of operations
•    traceable documentation of incidents and recovery

4. Choosing the Right Archiving Technology

The episode takes a deep dive into the security differences between modern archiving technologies.

Key points include:

•    Not all archives offer immutability
•    Some systems still rely on legacy file systems vulnerable to tampering
•    True GxP-ready digital archives must ensure:
o    immutability
o    auditability
o    verifiable integrity
o    transparent long-term retention policies

biomedion Watcher 4.0 is highlighted as an example of a secure, compliant, and future-ready solution — especially for laboratories that must meet strict regulatory requirements.

5. Building a Thoughtful IT Security Strategy in the Lab

Cybersecurity is not an isolated IT problem.
The experts stress that laboratories must integrate security into:

•    LIMS and ELN workflows
•    instrument networks
•    data-handling SOPs
•    backup and archiving processes
•    vendor and supply-chain interfaces

A secure archive alone is not enough — but it is one of the few components that remains trustworthy even after a successful ransomware attack.

Essential Takeaways From the Podcast

A concise summary of the strategies that strengthen cyber-resilience across regulated environments

The episode clearly outlines the core lessons for pharma and life-science organisations:

•    Downtime is more expensive than ransom.
•    Average downtime after a cyberattack is 20 days.
•    Efficient and tested incident-response plans are essential.
•    Preventive investment in cybersecurity significantly reduces long-term risk.
•    Immutable backups and secure archiving technologies are indispensable.
•    The archive is not just storage — it is your last line of defence.

How biomedion Supports Cyber-Resilient Pharma Operations

A concise summary of the strategies that strengthen cyber-resilience across regulated environments

biomedion’s solutions — especially Watcher 4.0 — are built to support the very strategies discussed in the episode:

•    GxP-ready, immutable long-term archiving
•    Full auditability and traceability
•    Protection against ransomware via WORM storage
•    Seamless integration into lab workflows
•    Support for offline copies and multi-layered backup strategies

These capabilities ensure that even if production systems fail, the integrity of critical data remains intact — enabling faster recovery and protecting regulatory compliance

Conclusion: Cybersecurity Is a Business Imperative in Pharma

The conversation between Julian Weber, Dr. Philipp Krubasik, and Lukas Schäfer makes one thing unmistakably clear:

Cybersecurity is no longer optional — it is fundamental to protecting patient safety, compliance, and business continuity.

Pharma companies must think long-term, invest in preventive measures, and ensure that their archiving and backup strategies are resilient, immutable, and aligned with NIST 2 and industry best practices.

Tune In and Stay Informed

Hear the full episode for deeper insights, examples & next-step suggestions

🎧 Listen now: DatenDokuDigital – Episode #4 "The Challenges of Data Archiving: Legacy Systems in Pharma"

Whether you work in quality management, research, regulatory affairs, or IT, DatenDokuDigital offers valuable insights for anyone driving digital transformation in the pharmaceutical industry.

Subscribe now: DatenDokuDigital – The Pharma Archive Podcast by biomedion

Have questions, feedback, or want to learn more about biomedion’s solutions?
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References and Further Reading:

Podcast Hosts:
🎙️ Julian Weber – Business Development Consultant, biomedion GmbH
🎙️ Dr. Philipp Krubasik – Head of Sales, biomedion GmbH

Guest Expert:
🎙️Lukas Schäfer –  Storage Solution Engineer, iTernity GmbH

Produced by STUDIO VENEZIA – the podcast company.

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