Data integrity issues have cost pharmaceutical and healthcare companies millions of dollars in direct and indirect costs and led to potential risks to patient safety. Companies are in a frenzy responding to regulatory citations and preparing for inspections. The industry, mostly from “lessons learned”, generally understands the issues; and the regulatory expectations have been communicated through a number of recent guidances (drafts, final, or effective) from the FDA, MHRA, EMA, WHO, and PIC/S. Now is the time for companies to be proactive with a holistic approach to establish/enhance processes and procedures to assure the integrity of their data throughout the entire data lifecycle.
Likely, every company is working to enhance their practices in respect to the way data is created, recorded, processed, reviewed, analyzed and reported, transferred, stored, and retrieved. ICH Guidance Q10, Pharmaceutical Quality System describes a comprehensive model for an effective pharmaceutical quality system (PQS). It has been further stated by the MHRA, EMA, WHO, and PIC/S that a Data Governance system should be an integral part of the PQS.
A Data Governance System is defined as “[t]he sum total of arrangements to ensure that data, irrespective of the format in which it is generated, is recorded, processed, retained and used to ensure a complete consistent and accurate record throughout the data lifecycle.” – from MHRA GMP Data Integrity Definitions and Guidance for Industry, March 2015.
Data Governance Systems should stress management’s responsibility for data integrity and encompass the following: Code of Ethical Conduct, Employee Training, Systems and Procedures regarding the control and security of raw data, Internal Audits by QA, Quality Metrics, Reporting and Investigation of Suspect Data Integrity breaches, Disciplinary Actions, Regulatory Agency Notification, and Data Integrity requirements with respect to outsourced services.
Although the lack of a formal Data Governance System may not yet have been cited as a regulatory observation, establishing such a system is the paramount step toward assuring data integrity. As Ben Franklin said, “By failing to prepare, you are preparing to fail.”. Is your Data Governance System providing the necessary guidance for success in assuring the integrity of your data?
For further information and training on the topic of Data Governance System and the importance of taking a proactive approach, please contact either R. George, Ph.D. at r.george@LachmanConsultants.com or J. Davidson, Ph.D. at j.davidson@LachmanConsultants.com
Some helpful references include:
- MHRA GMP Data Integrity Definitions and Guidance for Industry, March 2015
- MHRA GxP Data Integrity Definitions and Guidance for Industry, Draft version for Consultation, July 2016
- FDA draft Guidance, Data Integrity and Compliance with CGMP Guidance for Industry, April 2016
- 21 CFR, Part 58, Good Laboratory Practice for Non-Clinical Laboratory Studies”
- Parenteral Drug Association, March 2016 Data Integrity Code of Conduct (available for download here)
- WHO draft for comment, Guidance on Good Data and Record Management Practices (September 2015)
- FDA draft Guidance, Use of Electronic Health Record Data in Clinical Investigations – Guidance for Industry, May 2016,
- WHO Annex 5, Guidance on Good Data and Record Management Practices, July 2016
- PIC/S draft Guidance, Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments, August 2016
- EMA – GMP/GDP Compliance – Questions and Answers “Data Integrity” August 2016