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Software Validation & Data Integrity Audit

The integrity of data generated by business software systems is an essential part of business risk
management. Additionally, the Food and Drug Administration (FDA) expects that all data associated
with regulated products will be reliable and accurate throughout the data life cycle.
Data integrity is generally part of a software validation effort to ensure the adequacy of access controls,
audit trails and electronic signatures, and good documentation practices. Also, the protection of
regulated data must be ensured by deploying procedures. Data integrity encompasses the accuracy,
completeness, and consistency of GxP data over its entire life cycle. It involves defining all the steps for
practical management, control, and documentation.
A data integrity audit will review compliance documentation related to the following:

  • Security & access control
  • Change Control
  • Backup/Recovery
  • Disaster Recovery Planning
  • Audit Trail Integrity
  • Documentation Practices