Data Integrity continues to be one of the hottest topics in our industry and for very good reason. Without the necessary systems and/or processes in place to ensure data integrity throughout the product lifecycle, product quality and patient safety issues are more difficult to detect and therefore mitigate in a timely fashion.
It is important to understand what data integrity really means in order to be compliant. Data integrity refers to the fact that data must be reliable and accurate over its entire lifecycle. Data integrity and data security go hand in hand, even though they’re separate concepts. Uncorrupted data (integrity) is considered to be whole and then stay unchanged relative to that complete state.
Quality metrics, quality culture, and data integrity are of particular concern to both the industry and regulatory authorities. Pharmaceutical Online has published an interesting history of how these three areas have come together in establishing current global regulatory expectations.
Read the article here.