Guidance on good data and record management practices (WHO Guidance) -Annexure 5

Guidance on good data and record management practices (WHO Guidance) -Annexure 5

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 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. The data on which these decisions are based should therefore be complete as well as being attributable, legible, contemporaneous, original and accurate, commonly referred to as “ALCOA”.

1.2 These basic ALCOA principles and the related good practice expectations that assure data reliability are not new and much high- and mid-level normative guidance already exists. However, in recent years, the number of observations made regarding good data and record management practices (GDRP) during inspections of good manufacturing practice (GMP) (1), good clinical practice (GCP) and good laboratory practice (GLP) has been increasing. The reasons for the increasing concern of health authorities regarding data reliability are undoubtedly multifactorial and include increased regulatory awareness and concern regarding gaps between industry choices and appropriate and modern control strategies.

1.3 Contributing factors include failures by organizations to apply robust systems that inhibit data risks, to improve the detection of situations where data reliability may be compromised, and/or to investigate and address root causes when failures do arise. For example, organizations subject to medical product good practice requirements have been using validated computerized systems for many decades but many fail to adequately review and manage original electronic records and instead often only review and manage incomplete and/or inappropriate printouts. These observations highlight the need for industry to modernize control strategies and apply modern quality risk management (QRM) and sound scientific principles to current business models (such as outsourcing and globalization) as well as technologies currently in use (such as computerized systems). 

1.4 Examples of controls that may require development and strengthening to ensure good data management strategies include, but are not limited to: 

■ a QRM 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 take responsibility for good data management by first setting realistic and achievable expectations for the true and current capabilities of 168WHO Technical Report Series No. 996, 2016 WHO Expert Committee on Specifications for Pharmaceutical Preparations Fiftieth report a process, a method, an environment, personnel, or technologies, among others;

■ monitoring of processes and allocation of the necessary resources by management 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 supplies; to provide necessary training for personnel; and to allocate the necessary resources to the oversight of contract sites and suppliers to ensure adequate quality standards are met). Active engagement of 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 about failures so that management has an accurate understanding of risks and can then provide the necessary resources to achieve expectations and meet data quality standards: a reporting mechanism independent of management hierarchy should be provided for;

■ mapping of data processes and application of modern QRM and sound scientific principles throughout the data life cycle; 

■ ensuring that all site personnel are kept up to date about the application of good documentation practices (GDocP) 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 and subsequent change control, that all necessary controls for GDocP 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, which includes metadata and 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.

Good Data and Record Management practices