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TSMS-ANL-008

Analytical Data Integrity Study Guide

School of Analytical Chemistry · Advanced Analytical Chemistry · Intermediate

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Learning objectives

  • Define analytical data integrity.
  • Explain ALCOA+.
  • Distinguish raw data, metadata, and reports.
  • Describe audit-trail purpose.
  • Explain role-based access and electronic signatures.
  • Describe backup, retention, and investigation controls.

Executive summary

Data integrity is the assurance that analytical information remains complete, accurate, consistent, traceable, and protected throughout its lifecycle.

Reliable science requires more than a correct number. It requires a complete record showing:

- who performed the work,
- what method was used,
- which instrument generated the data,
- how the result was processed,
- what changes were made,
- who reviewed and approved it.

Key takeaways

  • Data integrity protects scientific evidence.
  • ALCOA+ provides a practical framework.
  • Raw data and metadata are both essential.
  • Audit trails support accountability.
  • Access controls and review preserve trust.
  • Backup and retention must maintain interpretability.

Self-review questions

  1. Why is metadata important?
  2. What does contemporaneous mean?
  3. Why are shared accounts a risk?
  4. What does an audit trail record?
  5. Why must backups be tested?

Use the full lesson to verify your answers.