MedTech/Pharma: Cybersecurity Remediation for a Validated System
What we succeed?
As a result of the partnership we established with Validfor, our test cycles shrink from weeks to days through one structured digital workflow and standardized workflows and centralized validation knowledge
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The Problem
Unsupported Server OS on a Critical Validated System Creating Regulatory and Security Exposure
A critical validated server OS reaches end-of-support, requiring security patches that introduce system changes — triggering the risk of losing validated state. Annex 11 periodic evaluation requirements include security, and PIC/S explicitly warns against unsupported systems and remote access vulnerabilities, making remediation both a cybersecurity and compliance obligation.
Critical validated server OS becomes unsupported — security patches require system changes
Risk of losing validated state during remediation without controlled change management
PIC/S explicitly warns against unsupported systems and remote access vulnerabilities
Annex 11 periodic evaluation scope includes security — non-remediation is a compliance gap
The Strategy
Controlled Security Remediation with Risk-Based Regression Testing and Validated State Documentation
The validation scope covered security remediation changes, regression testing, and documentation confirming that validated state is maintained post-patching — with change control governing each security update and fallback procedures documented to protect system recoverability.
Change control applied to all security remediation changes with security impact assessment
Risk-based regression test suite executed to confirm critical functionality unchanged
Document restoration and fallback procedures for each remediation step
Validated state documentation updated to reflect post-remediation system status
Validfor offers unparalleled traceability and control, ensuring that computerized systems remain compliant with industry standards.
Gizem Bozok
Quality Area Manager
The Solution
Remediated System Maintaining Validated State with Improved and Documented Security Posture
The system remains in a valid state following remediation, with critical functionality confirmed unchanged through regression testing. Security posture is measurably improved and fully documented — satisfying Annex 11 periodic evaluation requirements and eliminating the PIC/S-flagged vulnerabilities.
System remains in valid state post-remediation; critical functionality confirmed unchanged
Security posture improved and documented, satisfying Annex 11 periodic evaluation requirements
Restoration and fallback procedures in place, verified as part of the remediation process
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