There has been increasing focus on Data Integrity by the FDA and regulatory agencies worldwide. Data Integrity refers to maintaining and assuring the accuracy and consistency of data over its entire product life-cycle. Over the last few years, there has been an increase in the number of FDA Warning letters and 483s issued related to data integrity deficiencies.

Our highly experienced auditors conduct data integrity audits internally at your company and at your contract organizations. These audits can be conducted for both paper and electronic systems. We can help identify and remediate gaps and can provide guidance and training to assure on-going compliance.

Our auditors can assess:

  • Overall systems and processes (SOPs) for collecting and maintaining data
  • Review paper documentation for:
    • Proper documentation practices
    • To identify form deficiencies that contribute to errors or gaps
  • Verify raw data are retained in support of final results
  • Review computer-based systems:
    • Access and permissions/rights
    • Audit trails
    • Gaps in sequence or data files

In addition to data integrity audits, we can provide on-site customized training. Click here to learn more.