Data Integrity in QC Labs – HPLC, GC, Empower, LIMS, ELN
Data Integrity in QC Labs – HPLC, GC, Empower, LIMS, ELN
The most comprehensive guide for QA, QC, Laboratory Supervisors and Data Reviewers who must ensure compliant, robust and audit-ready data management within Quality Control laboratories.
It covers step by step all critical QC systems and data flows — HPLC, GC, Empower, LIMS, ELN, balances, dissolution, UV/IR, data review, OOS/OOT, backup and audit readiness — with a practical approach aligned with FDA, EMA and PIC/S expectations.
Inside you will find:
🔬 HPLC & GC Data Integrity: raw data, metadata, peak integration, reprocessing, common errors and what inspectors look for.
🧪 Empower Data Integrity: data structure, audit trail, typical errors and step-by-step best practices.
📚 LIMS & ELN: risks, key controls, correct configurations and practical applications.
⚙️ Other QC instruments: dissolution, UV/VIS, FTIR, balances, pH meters, loggers — with errors to avoid and key takeaways.
📝 Complete Data Review: primary review, secondary review, verification checklists and red flags to identify immediately.
📉 Integration with OOS/OOT: how to properly manage atypical results, investigations and data-related impacts.
💾 Backup & Data Lifecycle: controls, policies, compensatory measures and regulatory expectations.
🛡️ QC Audit Readiness: what FDA/EMA inspectors really assess, how to respond and which evidence must be ready.
📋 Operational Checklists & Templates: audit checklists for HPLC, GC, Empower, LIMS, ELN, data review, QC self-assessment, plus templates for DIRA and Audit Trail Review.
Perfect for QA Managers, QC Analysts, Supervisors, Data Reviewers, Validation/CSV Specialists and anyone aiming to build a truly audit-ready QC laboratory.
Format: Professional PDF
Pages: 137
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.