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Top Ten Data Integrity Traps

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How to Find and Fix Problems

A FDAnews publication

e-book

30 Seiten

1st edition 2016

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Techn. Voraussetzungen

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Is your data too good to be true? Are your procedures overly complex? If so, your data integrity may be at risk.

The Top Ten Data Integrity Traps report shows you where most data integrity problems occur and helps you create a plan to weed them out - and keep them out. You'll learn about 10 areas to watch for data integrity violations:

1. Quality culture
2. Batch records
3. Manufacturing floor
4. Raw vs. recorded data
5. Lab equipment
6. Analytical documentation
7. Document control
8. Lab control procedures
9. Material management
10. Personnel

This FDAnews Brief walks you through the 10 major areas of vulnerability and teaches you how to spot trouble in each. You'll learn how to:

Examine your organization's quality culture to make sure a commitment to data integrity starts at the top and is present in every aspect of your work
Evaluate your infrastructure to make sure your resources are adequate and employees aren't cutting corners
Verify that batch records and practices are under control
Identify data issues by walking the manufacturing floor
Evaluate your document control system and access to records
Check audit trails on your laboratory equipment
Determine the frequency of internal data audits based on risk analysis
Train employees to find and fix data problems before they become so entrenched that they cast doubt on the validity of every action, process and product

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Auditors
Quality control and quality systems officers
Compliance officers
Consultants/service providers
Data management and statistics personnel
Engineering and design controls teams
Executive management
General/corporate counsel
Manufacturing directors and supervisors

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