Nanosight has developed its NTA (Nanoparticle Tracking Analysis) software platform so that it may now be implemented within a CFR-compliant environment.
CFR 21 Part 11 is the part of the CFR21 guidelines, issued by the FDA, related to electronic record keeping and is primarily aimed at the pharmaceutical industry.
It pertains to a number of requirements for scientific instruments, such as providing suitable levels of access for different user and manager levels within the organisation; that records are stored in a protected way; and that data, if changed, should not replace or obscure the original data, and that the software has been developed in a responsible and reliable manner among others.
