Data Integrity and the ICH Q7 Guidance - Part II

In their 2004 document "PHARMACEUTICAL CGMPS FOR THE 21ST CENTURY - A RISK-BASED APPROACH" [6], the FDA explains their "Strategic Action Plan for Protecting and Advancing America's Health". The Agency's Strategic Plan identified efficient risk management as a key element: "Efficient risk management requires using the best scientific data, developing quality standards, and using efficient systems and practices that provide clear and consistent decisions …". Taking this plan into consideration, risk management, best scientific data and consistent decision making is calling out already for what we later call Data Integrity.

It is important to understand that (quality) risk management is essential to the implementation and maintenance of Data Integrity concepts. In order to control the risks they need to be categorized. Such a categorization must be simple and easy to be applied fast, consistently and reliably. A systematic approach is necessary to implement a holistic Data Integrity strategy. Such holistic and systematic approaches are based on a Data Integrity risk analysis, which is again the base for deriving governance concepts including master data. For the data (quality) strategy risks are collected in a register/inventory which also comprises measures and uses classifications to maintain an overview of the organization's data, systems, and processes throughout the lifecycle and to consistently control them. Libraries of such risks, measures, methods to GMP and Data Integrity ensure systematic, efficient and effective results. This includes the acceptance of risks!

As per practical experience, hybrid records (i.e. systems maintaining both paper and electronic records, typically with "paper lead") bear the highest risks to data and records, and are for that reason in the main focus of inspections and audits. Due to high efforts for the second person review of both paper and electronic records, and due to the need to assure that both are correct, consistent and synchronized, they expose the organizations to high financial and regulatory risks.

Since classical GMP regulations like ICH Q7 and the current Data Integrity standards are founded on the same basic principles, it rather seems to be a natural extension of the GMPs to the 21st century than a completely new metamorphosis - set by the authorities to assure the safety of the public and the best product quality.

To read the first part of this news, please see "Data Integrity and the ICH Q7 guidance - Part I".

References:
 [6] FDA, PHARMACEUTICAL CGMPS FOR THE 21ST CENTURY - A RISK-BASED APPROACH, FINAL REPORT, 2004