Data Integrity is a global mandatory requirement for the regulated healthcare industry. Developing a medical product and bringing it to market involves different players and activities. A fundamental step is linked to the robustness and accuracy of the data submitted by manufacturers to regulatory authorities. That data must be comprehensive, complete, accurate and, true to assure the quality of studies supporting applications for medical products to be placed on the market. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA). It also must comply with good manufacturing practices (GMP), good clinical practices (GCP), and good laboratory practices (GLP).
Data Integrity is a basic element of good documentation practices, one of the most fundamental pillars of any quality management system, including current good manufacturing practices. There has been a dramatic increase in the number of U.S. Food and Drug Administration (FDA) warning letters, World Health Organization (WHO) notices of concern, and EU statements of noncompliance in which false or misleading information has been identified during inspections. Failure to properly manage data integrity applies equally to paper and electronic data. It can arise either from poor systematic control of the data management systems due to a lack of knowledge, human error or from intentionally hidden, falsified or misleading data. Recently, a string of FDA-issued warning letters for data integrity violations has been published on the agency’s website. Between 2015 and 2016, major regulatory bodies, such as the European Medicines Agency (EMA), the FDA, the WHO, and the Pharmaceutical Inspection Co-operation Scheme (PIC/S), published guidance documents on the topic of data integrity and data management.
Our company can offer you the following services related to data integrity:
- Comprehensive Audits and Assessments to identify system weaknesses regarding your manual, electronic and hybrid data feed. We cover all aspects of your records and data recording practices specially laboratory systems and electronic storage.
- FDA inspection preparedness for Data Integrity including mock inspection.
- Remediation Consulting focused on FDA recommended best practices.
- Training for your personnel at all levels including a very comprehensive 3-day certification for managers and subject matter experts. Participants learn how to detect data integrity problems.