Compliance documents

Compliance documents

CAPA, RCA, deviations, risk assessments, change control, regulatory and audit documents.

CAPA

Corrective and preventive action formats and filled examples0 documents

Root Cause Analysis (RCA)

Fishbone, 5-Why, fault tree and investigation templates0 documents

Deviation / Investigation

Deviation, OOS, OOT and incident investigation reports0 documents

Risk Assessment

FMEA, HACCP, QRM and risk registers0 documents

Change Control

Change request, impact assessment and closure formats0 documents

Regulatory Document

Licences, dossiers, responses to regulators, site master files0 documents

Audit Checklist / Report

Internal, vendor and regulatory audit checklists and reports0 documents

Gap Assessment

Guideline gap analysis against Schedule M, EU GMP, FSSC and others0 documents

APQR / PQR

Annual and product quality review templates0 documents

Data Integrity

ALCOA+ assessments, audit-trail review and DI policies0 documents

All compliance CAPA Root Cause Analysis (RCA)Deviation / Investigation Risk Assessment Change Control Regulatory Document Audit Checklist / Report Gap Assessment APQR / PQR Data Integrity

All industries OSD Injectable Food Nutraceutical Other

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