08 Nov 21 CFR Part 11 Compliant Instruments
21 CFR Part 11 Compliant Instruments for the Pharmaceutical Laboratory
The US Food and Drug Administration (FDA) requires that FDA-regulated facilities, such as the pharmaceutical industry, comply with software regulations that are contained in the Code of Federal Regulations (CFR), Title 21, Part 11 in a document entitled “Electronic Records: Electronic Signatures”. These regulations guide how computer-generated data is stored and used. The electronic data must be traceable and cannot be altered. It is very important for laboratories that are regulated by the FDA to have laboratory instruments that have software compliant with these regulations.
A Krüss Optronic provides a large variety of products that are 21 CFR Part 11 compliant. Some of these products include:
FP8000 Flame Photometers
DS7000 Series Density Meters
MAT1000 Series Testers
P8000 Series Polarimeters