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World Health Organization (WHO) has issued a draft guidance document titled “Good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
Posted by Dr. Tim Sandle
