Data Integrity Audits and Assessments


NSF Health Sciences Pharma Biotech experts have conducted numerous data integrity reviews and audits, identifying data integrity issues and providing practical remediation solutions. We have helped companies lift import restrictions associated with data integrity observations and have assisted companies with data integrity reviews under the FDA’s Application Integrity Policy (AIP) and other international regulatory agency expectations.

Our audits review all aspects of your records and data recording practices including laboratory systems and electronic storage. We also verify the accuracy and reliability of data submitted in drug and biologic marketing authorization applications.

Our unique blend of former regulatory agency inspectors and industry professionals ensures that you receive a thorough and sound audit with no stone left unturned, pragmatic recommendations for improvements and remediation.

We provide:

  • Data integrity focused audits: Conducted by NSF Pharma Biotech experts, these audits provide findings and recommendations for closing gaps.
  • Third-party data integrity audits: Audits of CMOs, CTOs, CROs and other service providers or prospective suppliers.
  • Mock inspections with data integrity focus: Our staff of former FDA and MHRA regulators helps your company prepare for the real thing.
  • Data integrity assessments: A collaborative approach to identify system weaknesses and find solutions by utilizing our team’s expertise to your advantage.
  • Auditor training: NSF Pharma Biotech experts can demonstrate audit techniques in the field.

For more information about FDA and Health Canada related services in quality systems and compliance, email or call +1 202.822.1850.

For European and other international agencies, email or call +44 1751 432 999.

Why Work with NSF?

Challenge: A large Indian drug manufacturer was issued a warning letter regarding data integrity observations and contacted NSF Pharma Biotech.

Solution: NSF Pharma Biotech conducted a data integrity-focused audit and detected systemic weaknesses in both standalone and chromatographic data acquisition systems (CDAS). NSF Pharma Biotech then provided a corrective action plan (CAP) and recommendations and prioritization for addressing system weaknesses. Our client executed the CAP plan and resolved system deficiencies.

Six to Fix for Data Integrity

If your company is having data integrity issues, addressing these six items can help:

  • Involve top leadership. Senior management must set an example and promote data integrity in an open culture and must challenge the quality management system to ensure it is working.
  • Make sure you have a data governance system that provides an acceptable state of control based on the data integrity risks and that is fully documented with supporting rationale.
  • Ensure relevant policies are in place that detail what is required and what will you do if issues are identified.
  • Include the importance of data integrity in staff training. The training must cover the “why,” not just the “what.”
  • Understand and document the controls that are applied to the different areas of the quality system. Include both organizational (e.g. procedures) and technical (e.g. computer system access) controls.
  • Make sure that your internal audit and supplier audit programs have fully considered potential data integrity issues and that key areas of risk have been thoroughly investigated.

Our data integrity audits, and the resulting remediation plans, are trusted by pharmaceutical and biotech companies – and regulatory agencies – all over the world.  Our unique blend of former regulatory agency inspectors and industry professionals ensures that you receive a thorough audit with no stone left unturned and sound, pragmatic recommendations for improvements and remediation.