Data Integrity for GxP Regulated Industries

Lesson Code: DTI-1101 (PREMIUM LESSON) This e-Lesson is for personnel in GxP regulated industries who require underpinning knowledge of data integrity, its essential role in assuring product quality, and how personal responsibility is critical in maintaining compliance with data integrity regulations.

  • Category: Data Integrity

Description

After completing this e-Lesson, you will be able to:

  • Explain what is meant by ‘data integrity’ in relation to GxP records
  • Explain why data integrity is important in assuring product quality
  • Describe some of the consequences of data integrity failings
  • State where data integrity regulations apply in regulated industries
  • Describe the role of 21 CFR 11 in data integrity compliance
  • Explain the term ‘data life cycle’
  • Explain what is meant by an ‘original record’
  • Explain the purpose of an audit trail
  • Explain each of the ALCOA Data Integrity requirements
  • Describe some practical measures for ensuring data integrity in GxP regulated industries

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