Computerized System Validation (CSV) is no longer a static compliance exercise. In 2025, regulators made that clear.
Both the EMA and FDA introduced major updates that reshape how pharmaceutical and biotech companies must approach validation. The focus has shifted. Risk-based thinking, lifecycle management, data integrity, and system security are now front and center.
As we move into 2026, organizations that fail to adapt risk falling behind operationally and regulatorily.
Key CSV Regulatory Milestones in 2025
EMA Draft Annex 11 (July 2025)
The EMA released a substantially expanded draft of Annex 11 – Computerised Systems.
The document grew from 9 pages to 19. This is not cosmetic. It reflects a deeper regulatory expectation.
Key areas of emphasis include:
• Lifecycle management across system design, operation, and retirement
• Cybersecurity and identity/access management
• Audit trails and data integrity controls
• Supplier qualification and ongoing oversight
• Risk-based validation aligned with system criticality
The message is clear. CSV must be embedded into the Pharmaceutical Quality System (PQS), not treated as a standalone activity.
EMA Draft Chapter 4 (Documentation)
The updated draft of Chapter 4 reinforces expectations around data governance.
It places a stronger focus on:
• Metadata management
• Hybrid paper-digital workflows
• Traceability across systems and records
For many companies, this exposes gaps in how computerized records are governed once systems go live.
FDA Final Computer Software Assurance (CSA) Guidance (September 24, 2025)
The FDA finalised its long-awaited Computer Software Assurance (CSA) guidance.
CSA replaces large parts of the legacy, document-heavy validation mindset. Instead, it promotes:
• Risk-based testing based on intended use
• Least-burdensome documentation
• Unscripted and exploratory testing for low-risk functionality
• Focus on patient safety and product quality
This guidance aligns validation with modern software development and digital manufacturing realities.
Enforcement Trends
Regulatory expectations are tightening, and enforcement reflects it.
In 2025:
• FDA warning letters increased significantly
• Data integrity issues appeared in approximately 15% of all letters
• In some regions, data integrity findings accounted for over 60% of cited violations
Audit trails, access controls, and uncontrolled system changes remain common root causes.
Common CSV Challenges Exposed in 2025
Despite clearer guidance, many organisations struggle with execution.
Data Integrity Gaps
Missing or weak audit trails remain a critical issue. Manual interventions without traceability are frequently cited.
Hybrid and Cloud Systems
Cloud-hosted systems and hybrid architectures blur traditional validation boundaries. Responsibilities between vendors and system owners are often unclear.
Over-Validation
Some organizations still validate everything equally. This creates unnecessary workload and slows digital initiatives.
Weak Lifecycle Management
Validation does not end at go-live. Many companies lack structured periodic reviews, change control integration, or retirement strategies.
Practical Steps to Prepare for 2026
Organizations do not need to start from scratch. But they do need to adjust.
Adopt a Risk-Based CSV Strategy
Align validation effort with system impact. Focus testing on functions that affect patient safety, product quality, or data integrity.
Strengthen Audit Trails and Access Controls
Ensure audit trails are enabled, reviewed, and protected. Access rights should be role-based and periodically reassessed.
Integrate CSV into the PQS
CSV activities must connect with change management, deviation handling, and supplier oversight.
Modernize Validation Evidence
Leverage system-generated evidence. Screenshots, logs, and automated reports can replace excessive manual documentation.
Prepare for Annex 11 Finalization
EMA’s final Annex 11 is expected in mid-2026. Gaps identified now are easier and cheaper to close.
Proven Execution in Complex CSV Environments
Regulatory insight alone is not enough. Execution matters.
SEQOVA has delivered full-scope CSV programs across complex manufacturing and laboratory environments, including MES, LIMS, ERP, SCADA, PLC systems, and supporting IT infrastructure.
These projects demonstrate how risk-based validation, aligned with GAMP 5 and emerging CSA principles, translates into audit-ready operations and smooth production go-lives.
For a detailed example, see our CSV case study covering a full pharmaceutical manufacturing validation program.
Looking Ahead to 2026
The direction is clear.
CSV is becoming more strategic, not less. Regulators expect companies to understand their systems, control their data, and manage risk continuously.
Organizations that adapt early will not just remain compliant. They will gain speed, flexibility, and confidence in their digital operations.
For companies navigating CSV updates, hybrid systems, or upcoming inspections, now is the time to act.