ALCOA+ & Data Governance – The Definitive Operational Guide for Pharmaceutical Data Integrity
ALCOA+ & Data Governance – The Definitive Operational Guide for Pharmaceutical Data Integrity
The most comprehensive guide for QA, QC, IT, Manufacturing and Validation professionals who must implement a solid, modern and fully compliant Data Integrity system.
It provides an operational walkthrough of ALCOA+ principles, Data Governance, the Data Lifecycle and the full Data Integrity Risk Assessment (DIRA) process required by international standards.
Inside you will find:
📌 Practical explanation of the 9 ALCOA+ attributes, with examples and application across GMP departments.
🏛️ Data Governance model including roles, responsibilities, KPIs and integration within the PQS.
🔄 Complete management of the Data Lifecycle: generation → recording → processing → archiving → retrieval.
🛡️ Structured methodology to conduct an effective DIRA, with typical risks and actionable mitigations.
⚠️ Common issues identified by FDA/EMA (backdating, uncontrolled copies, disabled audit trails, unqualified data migrations).
📝 Professional templates: DIRA form, Data Integrity SOP, Audit Trail Review log, data-flow inventory, audit checklist.
🔍 Audit-ready approach for EMA/FDA inspections, with real examples of observed non-conformities.
Perfect for QA Managers, QC Analysts, Data Owners, IT/CSV Specialists, Production Supervisors and Validation Specialists.
Format: Professional PDF
Length: 92 pages
Updated: December 2025
Languages: ITA – ENG
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What will I find in this guide?
In addition to operational explanations of the relevant regulations, you will find checklists, templates, real-life cases, and common mistakes to avoid.
How up-to-date is the guide?
The guide includes updated references to the latest EMA and EU GMP regulations, as well as guidance from all international inspection bodies. In the event of future revisions, we expect updates to be made available to buyers.
How long is it and how long does it take to read?
Each guide has a specific length based on the complexity of the topic, but they are all designed for quick reference. You can use it as a daily reference manual.
Who is this guide most useful to?
Junior professionals → to learn quickly and reduce errors.
Senior professionals → to have ready-to-use checklists and templates to share with the team.
Can I download it multiple times or share it?
Once purchased, you can download and keep it. It is for personal or internal business use only, but external redistribution is not permitted.