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# New Data Auditing Process Needed: Consultant
- URL: https://www.fdaweb.com/new-data-auditing-process-needed-consultant/
- Published: 2017-02-16T12:00:00.000Z
- Updated: 2026-09-14T22:07:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138002

Unger Consulting says that the routine quality system approach to auditing can frequently fail to identify data management and data integrity problems and a new approach may be needed. In an online [paper](http://ungerconsulting.net/wp-content/uploads/2017/02/FINAL-UCI-BLOG-POST-DI-AUDITING.pdf?ref=fdaweb.com), the firm suggests that auditors should first focus on data management and data integrity to establish that the firm being audited produces trustworthy and valid data before pursuing more broad assessments of other aspects of the pharmaceutical quality system. The paper says that advantages to such an approach are that it: 

- reflects the seriousness FDA has identified for this issue with about 80% of drug GMP Warning Letters in FY 2016 citing governance and data integrity concerns;
- requires auditors to take a new approach and not permit themselves to be isolated in conference rooms evaluating standard operating procedures that can’t provide documented evidence about the trustworthiness of data generated by the auditee;
- can be performed with a limited number of auditors in a limited time duration;
- permits rapid determination of the validity and trustworthiness of data generated by the auditee and equates this with their overall GMP compliance status;
- provides a means of effectively qualifying and ensuring effective ongoing evaluations of key players in the drug supply chain based on documented evidence supported by trustworthy data; and
- allows evaluation of facility and equipment maintenance based on a facility walk-through with minimal extra effort.

 “The focused auditing approach … provides a means to more quickly determine the trustworthiness of GMP data that are necessary to ensure patient safety and product quality,” the report concludes. “It also supports an efficient use of limited resources. After the trustworthiness of the data are established, it is appropriate and necessary to move onto a more detailed evaluation of the quality systems. If data are determined not to be trustworthy, it suggests that the additional effort of evaluating the quality system may not be appropriate or value adding until the data management issues are remediated.”