GXP ACADEMY · DATA INTEGRITY & CSV
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.
DATA INTEGRITY · CSV · CSA
Audit trails, risk assessment, cloud systems, QC laboratories and the validation lifecycle explained through practical criteria, real cases and inspection expectations.
Discover Computer Software Assurance (CSA): the FDA revolution surpassing traditional validation. Critical thinking, fewer useless documents, and a focus on patient safety.
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The FDA is proposing a paradigm shift: less bureaucracy and more critical thinking in the validation of computerized systems. Learn the differences between CSA and CSV and how...
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How to qualify a cloud/SaaS vendor in a GxP environment: process, audit focus, Quality Agreement and continuous monitoring (SLA, change, incident).
How to qualify a cloud/SaaS vendor in a GxP environment: process, audit focus, Quality Agreement and continuous monitoring (SLA, change, incident).
Audit Trail Review: meaning, regulatory expectations and impact on quality and data integrity in QC and manufacturing processes.
Audit Trail Review: meaning, regulatory expectations and impact on quality and data integrity in QC and manufacturing processes.
What a DIRA is and why it is fundamental for ensuring Data Integrity, quality and GMP compliance in pharmaceutical companies.
What a DIRA is and why it is fundamental for ensuring Data Integrity, quality and GMP compliance in pharmaceutical companies.
CSA Practical Guide: Risk Assessment, Scripted vs. Unscripted Testing, and SaaS Vendor Management. Includes Templates and Strategies.
CSA Practical Guide: Risk Assessment, Scripted vs. Unscripted Testing, and SaaS Vendor Management. Includes Templates and Strategies.
IaaS vs PaaS vs SaaS: what “shared responsibility” really means in a GxP environment. Roles matrix, contracts and audit evidence.
IaaS vs PaaS vs SaaS: what “shared responsibility” really means in a GxP environment. Roles matrix, contracts and audit evidence.
How to validate a SaaS/Cloud system in a GxP environment: roles, risk assessment, IQ/OQ/PQ testing, data integrity, and post–go-live control.
How to validate a SaaS/Cloud system in a GxP environment: roles, risk assessment, IQ/OQ/PQ testing, data integrity, and post–go-live control.
PRACTICAL GMP TOOLS FOR PHARMA
GuideGxP turns complex GMP requirements into operational guides, editable templates and practical insights for pharmaceutical professionals.
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