The importance of maintaining the quality and reliability of the data (Data Integrity) submitted to the authorities, especially in the field of pharmaceuticals, has become a binding requirement. As part of the global transition to computerized, automated systems and software in the past thirty years, and in order to ensure that critical electronic data presented to the authorities as a basis for decision-making are accurate and reliable, some methodical official guideline documents have been published by the health authorities.
A compliance document of the US Food and Drug Authority (FDA) namely 21 CFR Part 11 was published in the late 1990s. It was followed by other documents such as EU Annex 11 by the European Authorities, as well as similar documents for the Canadian, Australian and other International Health Authorities. The authorities consider violations of these principles severely, and a reference for that can be found in the FDA’s warning letters.
As part of the regular review, the purpose of the authorities is not only to identify problems and serve as gatekeepers, but also to help the companies to improve. In recent years, clarification documents have been published attempting to find the right ways to facilitate learning and understanding. One way is to bind the requirements under the acronym ALCOA+, in which each letter represents a set of regulatory requirements. These requirements are obligatory; however, it is not always easy and obvious to do so. The purpose of this acronym is to allow international alignment, addressing discourse and harmonization in order to enable effective assimilation of the regulatory requirements.