Deviations and corrective and preventive measures (CAPA) are among the most important, practical and key concepts of quality assurance in the pharmaceutical industry. Deviation refers to the difference between expected or normal values and observed values for a product or process. These deviations can occur during testing, sampling, manufacturing or acceptance of raw materials and finished products. The process of dealing with deviations includes identifying their criticality, performing root cause analysis and proposing corrective and preventive measures. FDA guidelines emphasize documenting procedures for stopping operations, recording nonconformances, investigating discrepancies, and implementing corrective actions. The general concept of deviations is any difference between instructions, processes and rules and conditions defined by high-level documents in production and non-production space. The quality assurance department is required to collect these events from the reporters and detect possible deviations during the implementation of a predefined process, and if the deviation is significant, corrective and preventive measures must be taken by implementing the CAPA process to achieve follow up on results and effectiveness.
All processes for deviation and CAPA registration and follow-up are fully paperless and automated in 7 steps.