Data integrity has become a major challenge to the pharmaceutical industry as equipment becomes increasingly computerized. Data is no longer represented by a simple printout or a value on the screen; instead it consists of many parameters and calculations and can, in some cases, even be re-processed to display result differently. All the data we create during product manufacturing and analysis must maintain its integrity and follow ALCOA plus principles throughout the life cycle of the product. Reliable data is key in guaranteeing that products are safe for patients. To ensure this, computerized systems are used to generate data and are these systems must undergo validation to demonstrate they are fit for purpose.
Computerized Systems Validation (CSV) consists of documented evidence that a computerized system adheres to ALCOA plus principles. Ensuring this adherence to through technical controls is challenging and often quite complex and time-consuming. The requirements to meet ALCOA plus come from 21 CFR Part 11 (FDA) and Eudralex GMP Annex 11 (EU), and apply to all computerized systems. As these are interpreted by the manufacturers of such computerized systems and translated into technical capabilities built into the systems, differences in the capability of meeting these principles inevitably arise, which carries challenges for the companies using them in GMP settings.