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Top Ten Data Integrity Traps

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How to Find and Fix Problems

A FDAnews publication

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30 Seiten

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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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