In a modern fast-moving world many sectors, including the life sciences industry has started to rely on computer and automated systems to a great extent, whether in terms of manufacturing or laboratory release testing. Consequently, there is a renewed focus on the accuracy and consistency of data over its entire lifecycle.
For several years, the FDA and other global regulatory bodies have emphasised the importance of accurate and reliable data in assuring drug safety and quality. However, in tandem with increased digital sophistication and the role of global manufacturing partners, data integrity violations have been on the rise.
Our group contains a number of data integrity experts with manufacturing, QA and IT experience working in major pharmaceutical manufacturing companies. Using this experience, we have been able to assist clients in developing data integrity policies, plans & procedures as well as help carryout audits and risk assessments.