Save 10% before you check out
Apply code AUGUST10 by 31 August 2026. The discount will be shown at checkout.
Apply AUGUST10One use per customer · Cannot be combined
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.
The EU GMP Annex 11 revision 2025 rewrites the rules for computerised systems: 17 chapters with a strong focus on security, audit trails, access management and cloud services....
Read the article →
A practical guide to determining when 21 CFR Part 11 applies, implementing proportionate electronic record and signature controls, and comparing it with EU GMP Annex 11.
Read the article →
Strategies to pass FDA/EMA audits on IT systems. Focus on Data Integrity, Vendor Management for the Cloud, and Change Control.
Read the article →
ALCOA+ in the cloud: how to configure audit trails, roles, electronic signatures and operational reviews to remain compliant (Part 11 / Annex 11).
Read the article →
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.
Read the article →
What inspectors really check in QC labs and how to avoid critical Data Integrity deviations. Audit-ready approach.
Read the article →
What inspectors really evaluate during Audit Trail Review and how to demonstrate full audit readiness.
Read the article →
How to pass EMA/FDA audits with a structured and fully documented DIRA.
Read the article →
The EU GMP Annex 11 revision 2025 rewrites the rules for computerised systems: 17 chapters with a strong focus on security, audit trails, access management and cloud services. Here is...
The EU GMP Annex 11 revision 2025 rewrites the rules for computerised systems: 17 chapters with a strong focus on security, audit trails, access management and cloud services. Here is...
A practical guide to determining when 21 CFR Part 11 applies, implementing proportionate electronic record and signature controls, and comparing it with EU GMP Annex 11.
A practical guide to determining when 21 CFR Part 11 applies, implementing proportionate electronic record and signature controls, and comparing it with EU GMP Annex 11.
Strategies to pass FDA/EMA audits on IT systems. Focus on Data Integrity, Vendor Management for the Cloud, and Change Control.
Strategies to pass FDA/EMA audits on IT systems. Focus on Data Integrity, Vendor Management for the Cloud, and Change Control.
ALCOA+ in the cloud: how to configure audit trails, roles, electronic signatures and operational reviews to remain compliant (Part 11 / Annex 11).
ALCOA+ in the cloud: how to configure audit trails, roles, electronic signatures and operational reviews to remain compliant (Part 11 / Annex 11).
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.
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.
What inspectors really check in QC labs and how to avoid critical Data Integrity deviations. Audit-ready approach.
What inspectors really check in QC labs and how to avoid critical Data Integrity deviations. Audit-ready approach.
PRACTICAL GMP TOOLS FOR PHARMA
GuideGxP turns complex GMP requirements into operational guides, editable templates and practical insights for pharmaceutical professionals.
