In the pharmaceutical manufacturing field, it is critical that computerized systems comply with the U.S. FDA’s 21 CFR Part 11 and EU Annex 11 regulations to ensure data accuracy, integrity and reliability, and sample preparation is no exception.
For pharmaceutical QA/QC testing labs conducting trace-elemental analyses, PerkinElmer’s MPS 320™ microwave digestion system delivers the flexibility you need for a variety of applications, while providing both confidence in your results as well as in your compliance to 21 CFR Part 11 and EU Annex 11 regulations. The software of the MPS 320 microwave provides features that, when coupled with appropriate policies and procedure, fulfill the requirements for closed-system electronic records, as well as the elements relating to electronic signatures.