Data Integrity has become a necessity for ensuring safety of medicine, and helping to assure release tests to be correct and not corrupted. This emanated as a message recently at a Pharmig conference, which was held in Slovenia. Data integrity implies assuring and maintaining the consistency and accuracy of data through its overall life-cycle. It is an imperative aspect to design, implement and use any system that stores, processes or retrieves the data.
Data Integrity has Gained Focus of Regulatory Bodies
New developments equipped with computerized systems are making the data security stronger. These developments form an integral aspect of the healthcare and pharmaceutical sectors’ digital transformation. A major concern however is the mismatch between the requirements of the industry and the provisions of electronic systems manufacturers. Data integrity has gained the focus of major pharmaceutical regulators, including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), who are discerning data integrity as fundamental for codes that require to be in intended place for production and distribution of medicines.
At the Pharmig conference, which aimed at laboratory managers, microbiologists, and pharmacists, two presentations dealt directly with data integrity. The first was offered by a Site Microbiologist, David Keen, at the U.K. GlaxoSmithKline site. Keen’s presentation focused on sharing best practices, from laboratory to laboratory. Keen viewed at data integrity within microbiology laboratory and requirements for good data integrity that are summarized under “ALCOA” (Attributable, Legible, Contemporaneous, Original, and Accurate). Keen offered a useful framework for medical equipment manufacturers for developing appropriate data controls. The metadata concept was also introduced that provides context or meaning of data. Keen also discussed about data lifecycle, which involves processing, retrieval, archiving, use, and destruction of data (whenever needed).
Ensuring Data Integrity Requires Computerized Systems with Password Controls
Second presenter, Bruno Simek, managing director of Arguo d.o.o. – a pharmaceutical consulting company – focused on capturing data, either by electronic systems or various other types of documentation. According to Simek, ensuring data security requires computerized systems designed with password controls and full audit trails. This helps the person designated for approval of final results in reviewing every entry and related records for ensuring the originality of the results. Here organizational culture is crucial, as practices and behaviors of personnel might result into errors albeit equipped with well-designed systems.
Control over raw data was also emphasized at the conference. With raw data, the original documentation and record could be retained in the format similar to that when it was originally generated. It may also refer to the document retained as true copy. This further introduces the complexity in relation between metadata and raw data in terms of the reviewing, storing, and retrieving the data.
Presentations offered by Keen and Simek shed light on the criticality of data integrity for the pharmaceutical sector, and its stand as a hot topic for regulatory bodies. This can further aid an auditor to gain knowledge about the entire status of an organization. When issues associated with data integrity would occur, the auditor could identify these as a sign of the organization’s poor quality culture.