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Laboratory Automation & IT Solutions
New White Paper - Data integrity
Data integrity in the context of laboratory analytics is a must, particularly in regulated environments. However, how is data integrity exactly defined, and what are the software features required to achieve it?
A new Metrohm white paper answers these questions based on examples from modern Near-Infrared Spectroscopy (NIRS) Software.
Data integrity is commonly defined by a number of properties, which are summarized by the acronyms ALCOA and ALCOA+, respectively. Hence, ALCOA stands for «attributable», «legible», «contemporaneous», «original», and «accurate», while ALCOA+ extends these attributes by the properties «complete», «consistent», «enduring», and «available».
The new white paper explains these properties in detail and gives examples for each of them based on Metrohm’s NIRS software Vision Air.
From the present white paper, a clear picture emerges of the functionalities that state-of-the-art laboratory software should provide in order for laboratories to safeguard the integrity of their data and comply with, e.g., the requirements of FDA 21 CFR Part 11. At the same time, the present white paper emphasizes that compliant-ready software such as Vision Air can only provide a solid base to achieve data integrity and does not spare companies from establishing a solid framework of standard operating procedures.