Published in: Productivity Press
Published on: December 21, 2020
In drug manufacturing, quality is viewed as a required objective to be achieved through the management of the production process. Data are the results of the production process, and the way this process is performed affects data accuracy. The set of control procedures applicable to data integrity must be sufficiently comprehensive to provide evidence of operational and quality system activities. Data integrity covers data entry or collection, data storage, data transmission, and data processing. Data provenance is the assurance of the data source systems. Data validity is about the correctness and reasonableness of data conforming to the syntax and structure defined by the business requirements. Instead of regulated companies emphasizing data integrity, it is suggested companies concentrate on data quality to meet quality requirements, as contained in the respective medicine manufacturing practices regulations.