Looking for the best way to integrate UV-Vis technology into pharmaceutical quality assurance (QA), quality control (QC), or research environment? In this on-demand webinar, Dr. Daniel Frasco, product specialist at Thermo Fisher Scientific, explains why the Evolution UV-Vis spectrophotometer could be the ideal solution.
Read on to gain information and insights on the tools available for instrument validation and qualification, performance verification, and data integrity, and learn how Thermo Fisher Scientific can work in tandem with pharmaceutical companies to deliver streamlined integration of new instrumentation into a pharmaceutical environment.
Q: Does the 21 CFR Part 11 require any specific data storage format?
MI: No, 21 CFR Part 11 does not require any specific data storage format. However, what it does call out is when the data needs to be able to be audited and digitally signed. Any changes to the data need to be recorded and managed, the Thermo Fisher software can absolutely do that.
Q: When should the frequency performance verification be worn?
MI: 21 CFR does not provide any specific recommendations. Typically, our pharmaceutical customers have their own operating procedures that are driven by other quality standards within these organizations. The frequency of validation and qualification is typically driven by the standard operating procedures (SOPs) within these organizations.
Q: What is the principal operation of HPLC and UV visible spectrometers?
MI: HPLCs and UV spectrophotometers are different classes of instruments. UV spectrophotometers are complicated instruments but, in principle, there is a source of light that passes through the sample that is under examination. The sample properties cause it to absorb light in a certain valence. The amount of light that passes through the sample is measured using a photometric sensor on the other side and, depending on how much light is measured, insight can be derived regarding the composition or certain properties of the sample. So, that is a quick explanation of the principle of UV spectrophotometers, specifically.