You can access your Annex 11 Readiness Checker results below. If you wish, you can download the report and contact us for more features.
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Section Scores
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Compliance Profile
Performance across the 5 core regulatory pillars.
Identified High-Risk Gaps
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CRITICAL
Insufficient Audit Trail Granularity
The system fails to capture “Reason for Change” metadata for records modified during clinical validation phases.
Recommendation: Enable mandatory 'Reason Code' prompts for all field-level updates.
CRITICAL
Insufficient Audit Trail Granularity
The system fails to capture “Reason for Change” metadata for records modified during clinical validation phases.
Recommendation: Enable mandatory 'Reason Code' prompts for all field-level updates.
Complaince Strengths
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Excellent
Advanced Password Complexity
System enforces 12+ characters mixed-case requirements and 90-day rotation cycles, exceeding FDA baseline.
Good
Time-Stamping Integrity
All record entries use a centralized NIST-synchronized server clock, preventing local manual oveerrides.
Good
Limited System Access
RBAC is strictly defined with zero ‘Default All’ permissions founds.
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