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Clinical_Protocol_v2.1.pdf · ICH E6 (R3)
Overall Compliance Score
Based on ICH E6 (R3) Requirements
E-signature implementation meets requirements. Validation documentation present, audit trails configured, user authentication enforced per 21 CFR 11.100.
Backup procedures should be strengthened. Recommend implementing automated data verification checks to replace current manual processes, per ALCOA+ attributable and contemporaneous principles.
No documented periodic audit trail review process. EU Annex 11, Section 9 requires routine review. Recommend establishing SOP with defined review frequency and responsible personnel.
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URS, IQ, OQ, PQ protocols, traceability matrix, validation summary report
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ALCOA+ tools, data integrity SOPs, audit checklists, remediation templates
FDA inspection readiness, mock audit templates, 483 response templates
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Step-by-step guide to achieving and maintaining compliance with FDA's electronic records and signatures requirements.
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Comprehensive checklist covering all operational and IT requirements of Annex 11 for computerized systems.
Summary of key updates in GAMP 5 Second Edition and practical implications for your validation strategy.
A practical methodology for evaluating third-party and COTS software in GxP regulated environments.
Evaluate your organization's data integrity posture against ALCOA+ principles and current regulatory expectations.
Navigating the IMDRF risk categorization framework for Software as a Medical Device, including IEC 62304 implications.
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