In recent years, FDA has increasingly observed CGMP violations involving data integrity during FDA inspections and other regulators. These have led to numerous regulatory actions, including warning letters.
This video should show how the data integrity requirements can be fulfilled with the LabX laboratory system. This system is able to connect a variety of laboratory instruments and fulfills all requirements regarding 21 CFR 11, EU Annex 11, ISO 17025.
Learn more about LabX at https://www.mt.com/global/en/home/products/laboratory-software/labx-software.html?cmp=smo_GLO_YT_LAB_OTH_Youtube_LAB_5q5NXhycU_Q