Course Code: ELM-102-13

What is Laboratory Data Integrity? [Video]

Some dictionary definitions of integrity are:

  1. The quality of possessing and steadfastly adhering to high moral principles and professional standards
  2. The state of being whole and undivided
  3. The state of being sound and undamaged

From the perspective of the patient, client or customer who needs to know that the results can be relied upon; this can be applied to the integrity of laboratory data as delivering results which are accurate, precise and consistent, and maintaining records thereof over their entire life cycle in conformance with applicable regulations.

This is consistent with the principles of the ICH guidelines on pharmaceutical quality management.

Author

Dr. David Trew

Organic & Analytical Chemist David Trew Consulting Ltd