Audit Trail in Pharma: What It Is and How to Manage It
What is an audit trail? What EU GMP Annex 11, 21 CFR Part 11 and PIC/S PI 041-1 require and how to set up a risk-based audit trail...
Read the article →GXP ACADEMY · DATA INTEGRITY & CSV
Data Integrity and CSV: controlled systems, defensible data.
Practical analysis of ALCOA+, Annex 11, 21 CFR Part 11, CSV and CSA, Audit Trail Review, DIRA, SaaS and cloud systems. Built to govern the data lifecycle, apply risk-based controls and prepare robust evidence for audits and inspections.
✓ ALCOA+ · Data lifecycle
✓ Annex 11 · Part 11
✓ CSV · CSA · Cloud
DATA INTEGRITY · CSV · CSA
Controls and evidence for genuinely audit-ready systems.
Audit trails, risk assessment, cloud systems, QC laboratories and the validation lifecycle explained through practical criteria, real cases and inspection expectations.
CSV Inspections: How to Defend Computerized Systems and the Cloud in an Audit
Strategies to pass FDA/EMA audits on IT systems. Focus on Data Integrity, Vendor Management for the Cloud, and Change Control.
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Data Integrity (ALCOA+) in SaaS/Cloud: controls and audit trail
ALCOA+ in the cloud: how to configure audit trails, roles, electronic signatures and operational reviews to remain compliant (Part 11 / Annex 11).
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FDA Inspections and CSA: How to Demonstrate Compliance Without Unnecessary Documentation
Prepare your CSA strategy for an audit. What do FDA/EMA inspectors look for? How to justify Risk-Based Testing and the use of exploratory tests.
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FDA/EMA Audit: How to Demonstrate Data Integrity in QC
What inspectors really check in QC labs and how to avoid critical Data Integrity deviations. Audit-ready approach.
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Audit Trail Review: how to prepare for an FDA/EMA audit
What inspectors really evaluate during Audit Trail Review and how to demonstrate full audit readiness.
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DIRA Data Integrity Risk Assessment for GMP Audits
How to pass EMA/FDA audits with a structured and fully documented DIRA.
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Data Integrity in QC: Practical Step-by-Step Guide
How to apply data integrity in the QC laboratory: procedures, checks, common errors, and operational checklists. A comprehensive, audit-ready guide.
Read the article →Data Integrity & CSV
GAMP 5 Categories with Examples: 1, 3, 4 and 5
GAMP 5 categories with examples: how to classify software in categories 1, 3, 4 and 5 and scale validation effort accordingly. Plus what changed in the Second Edition (2022) and...
GAMP 5 Categories with Examples: 1, 3, 4 and 5
GAMP 5 categories with examples: how to classify software in categories 1, 3, 4 and 5 and scale validation effort accordingly. Plus what changed in the Second Edition (2022) and...
Data Integrity Risk Assessment Template (DIRA) ...
A data integrity risk assessment (DIRA) is the documented evaluation that maps GxP data flows, rates their criticality and vulnerability, and defines proportionate controls. Template structure, step-by-step completion and typical...
Data Integrity Risk Assessment Template (DIRA) ...
A data integrity risk assessment (DIRA) is the documented evaluation that maps GxP data flows, rates their criticality and vulnerability, and defines proportionate controls. Template structure, step-by-step completion and typical...
Audit Trail in Pharma: What It Is and How to Ma...
What is an audit trail? What EU GMP Annex 11, 21 CFR Part 11 and PIC/S PI 041-1 require and how to set up a risk-based audit trail review. A...
Audit Trail in Pharma: What It Is and How to Ma...
What is an audit trail? What EU GMP Annex 11, 21 CFR Part 11 and PIC/S PI 041-1 require and how to set up a risk-based audit trail review. A...
CSV Inspections: How to Defend Computerized Sys...
Strategies to pass FDA/EMA audits on IT systems. Focus on Data Integrity, Vendor Management for the Cloud, and Change Control.
CSV Inspections: How to Defend Computerized Sys...
Strategies to pass FDA/EMA audits on IT systems. Focus on Data Integrity, Vendor Management for the Cloud, and Change Control.
Data Integrity (ALCOA+) in SaaS/Cloud: controls...
ALCOA+ in the cloud: how to configure audit trails, roles, electronic signatures and operational reviews to remain compliant (Part 11 / Annex 11).
Data Integrity (ALCOA+) in SaaS/Cloud: controls...
ALCOA+ in the cloud: how to configure audit trails, roles, electronic signatures and operational reviews to remain compliant (Part 11 / Annex 11).
FDA Inspections and CSA: How to Demonstrate Com...
Prepare your CSA strategy for an audit. What do FDA/EMA inspectors look for? How to justify Risk-Based Testing and the use of exploratory tests.
FDA Inspections and CSA: How to Demonstrate Com...
Prepare your CSA strategy for an audit. What do FDA/EMA inspectors look for? How to justify Risk-Based Testing and the use of exploratory tests.
