Auditing the quality system for data integrity

Presentation at the 2019 ASQ Audit Conference.

Data integrity is one of the hot topics of regulatory agency inspections of pharmaceutical and medical device manufacturers and is relevant to many industries. Many companies struggle with the concepts of data integrity as it involves both paper and electronic data, dealing with legacy computer systems and the organization culture. This session will provide a brief regulatory overview and then lay out the core principles of data integrity:

  • Organizational culture should drive ALCOA
  • Data governance is part of the management review process
  • Data Risk Assessments with appropriate mitigations (full risk management approach)

The Quality Management System needs to have key processes and tools for the prevention, detection, analysis, reporting, tracking and remediation of noncompliance to these data integrity principles built in that:

  • Prevent data integrity issues through governance, training, organizational controls, processes, systems underlying and supporting data integrity.
  • Detect data integrity issues through leveraging existing Quality Systems, tools and personnel.
  • Remediate data integrity issues through leveraging existing Quality Systems that identify and track implementation of corrective/preventive action(s).

Based on these principles this session will provide tools to:

  • Apply a situational awareness to an organization
  • Analyze the technical and cultural hurdles focusing on the core areas of governance, training, organizational controls, process and systems
  • Create and utilize data maps to drive detection and remediation
  • Apply mitigations to the common cultural hurdles