From Backup to Bounce Back: Why Emergency Readiness in Pharma Starts with Testing

In the pharmaceutical and biotech industries, compliance and continuity are more than just buzzwords, they’re business-critical imperatives. Yet, many organizations still treat data backup as a passive safety net rather than an active part of their emergency readiness strategy. The reality? A backup that hasn’t been tested is a risk, not a safeguard.

Why Backup Testing Matters 

IT outages and disruptions are no longer rare events, they’re daily realities. Regulatory bodies like the FDA, EMA, and MHRA are no longer satisfied with vague assurances of data protection. They expect documented, validated recovery procedures, especially for systems that support GxP processes.

Frameworks like GAMP5 and Computer System Validation (CSV) now emphasize the importance of tested backup and restore processes. If your organization can’t prove that a restored system performs exactly as it did before, you could be facing regulatory penalties and audit failures.

Real-World Risks: Cyber Threats and Compliance

Pharma and biotech companies are increasingly targeted by ransomware and other cyber threats. These attacks don’t just disrupt operations — they can compromise sensitive data, delay production, and damage your brand’s reputation. That’s why cyber resilience is no longer optional. It’s essential.

Expert Insight

Backup Testing: The Often-Ignored Link in Business Continuity

Many companies assume that having a backup is enough. But without regular, structured testing, you won’t know if your backups are:

• Up to date
• Isolated from threats
• Capable of full system recovery

A robust backup strategy includes testing functionality, validating restore accuracy, and ensuring infrastructure alignment with your business continuity goals.

Best Practices for Backup Testing

1. Integrate Testing into Release Cycles
   Don’t treat backup restore as a separate, periodic exercise. Incorporate it into your regular release schedule and use backups to restore test environments. This approach validates both procedures and data consistency.

2. Adopt Real-World Testing Methods
   Forward-thinking organizations are adopting real-world testing methods to prepare for the unexpected:
   • Tabletop Exercises simulate cyber incidents to test response plans.
   • BOB Tests remove key personnel from the equation to assess true operational resilience.

These exercises help identify gaps in your recovery strategy, before a real crisis does.

3. Document Everything, And Keep It Updated
   Detailed, regularly updated Standard Operating Procedures (SOPs) are essential for both backup and restore processes. Ensure everyone knows how to perform and restore backups, not just your “Bob” or key recovery expert. Regularly review and update these documents to reflect changes in systems and regulations.
4. Risk-Based Asset Prioritization
   Rank assets by business impact and allocate resources accordingly. Balance compliance, risk, and budget to ensure high-value systems receive appropriate protection.
5. Validate Integrations and Data Consistency
   Test all new releases on the most recent copy of production environments, including core ERP and all integrated applications. Watch out for out-of-sync backups, which can undermine recovery efforts.

Cloud or On-Prem? Tailor to Your Risk Profile

Choosing between cloud-based and on-premise backup solutions isn’t just a technical decision, it’s a compliance and risk management decision. Each option has its pros and cons:

• Cloud offers flexibility and scalability but may raise concerns around data sovereignty and validation.
• On-prem provides control and traceability but can be harder to scale and protect.

The right choice often lies in a hybrid approach, tailored to your regulatory environment and operational needs.

Building a Culture of Emergency Readiness

Cyber resilience and backup testing shouldn’t be isolated IT projects, they must be embedded in your daily business culture.

• Make testing part of your regular operations, not just a last-minute scramble before audits.
• Document and track your testing results, using scorecards or KPIs to hold teams accountable.
• Learn from each test and continuously improve your plans and procedures.

Conclusion: From Passive Backup to Active Resilience

Emergency readiness starts with testing. By embedding backup validation into your business processes, documenting procedures, and prioritizing risk, you transform backups from a passive safety net into an active shield against disruption. When the next cyber event or outage strikes, you’ll be ready to bounce back; quickly, confidently, and compliantly.

Ready to Strengthen Your Emergency Readiness?
At Cegeka we help organizations build resilient, compliant, and testable backup strategies that stand up to both audits and attacks.

Watch our On-demand webinar where we explored real-world examples and practical steps you can take to protect your systems and your reputation or contact us to learn more.