Wednesday, 18 November 2015

WHO Good Data and Record Management Practices

The World Health Organization (WHO) has issued a draft guidance document titled “Good Data and Record Management Practices.” The document is out for public comment.

Medicines regulatory systems worldwide have always depended upon the knowledge of organizations that develop, manufacture and package, test, distribute and monitor pharmaceutical products. Implicit in the assessment and review process is a trust between the regulator and the regulated that the information submitted in dossiers and used in day-to-day decision-making is comprehensive, complete and reliable. Data on which these decisions are based should therefore be complete as well as being accurate, legible, contemporaneous, original and attributable; commonly referred to as “ALCOA”.

The draft discusses the controls necessary for good data management, which include:

A quality risk management approach that effectively assures patient safety and product quality and validity of data by ensuring that management aligns expectations with actual process capabilities. Management should govern good data management by first setting realistic and achievable expectations for the true and current capabilities of a process, method, environment, personnel, technologies, etc.;

Management should continuously monitor process capabilities and allocate the necessary resources to ensure and enhance infrastructure, as required (for example, to continuously improve processes and methods; to ensure adequate design and maintenance of buildings, facilities, equipment and systems; to ensure adequate reliable power and water; to provide necessary training for personnel; to allocate the necessary resources to the oversight of contract sites and suppliers to ensure adequate quality standards are met, etc.). Active engagement by management in this manner remediates and reduces pressures and possible sources of error that may increase data integrity risks;

Adoption of a quality culture within the company that encourages personnel to be transparent in failures so that management has an accurate understanding of risks and can then provide the necessary resources to achieve expectations and data quality standards;


Mapping of data processes and application of modern quality risk management and sound scientific principles across the data life cycle;

Modernization of the understanding of all site personnel in the application of good documentation practices to ensure that the GxP principles of ALCOA are understood and applied to electronic data in the same manner that has historically been applied to paper records;

Implementation and confirmation during validation of computerized systems that all necessary controls for good documentation practices for electronic data are in place and that the probability of the occurrence of errors in the data is minimized;

Training of personnel who use computerized systems and review electronic data in basic understanding of how computerized systems work and how to efficiently review the electronic data and metadata, such as audit trails;

Definition and management of appropriate roles and responsibilities for quality agreements and contracts entered into by contract givers and contract acceptors, including the need for risk-based monitoring of data generated and managed by the contract acceptor on behalf of the contract giver;

Modernization of quality assurance inspection techniques and gathering of quality metrics to efficiently and effectively identify risks and opportunities to improve data processes.

To access the draft see: WHO

Posted by Dr. Tim Sandle

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