Varian, Inc.'s Optical Spectroscopy and Chromatography Product Lines Help Pharma Customers Achieve Compliance With U.S. FDA 21 C
AA, ICP and UV-Vis Instrument Users Ensured Electronic Signature of Secure Electronic Records
The additional measures, which control and monitor access to spectroscopy systems and data within the pharmaceutical analysis process, and allow electronic signature of these now secure electronic records, assist pharmaceutical customers to comply with strict regulatory requirements that affect validation of pharmaceuticals over the course of development. Specific security functions in the Windows(R)-based software platform include audit logs that record all instrument operations and secure record storage to prevent unauthorized access or tampering.
ICP-OES and AA spectrometers are most commonly used in the pharmaceutical industry for research and development and for quality assurance and quality control (QA/QC) of drugs and their associated packaging. In particular, pharmaceutical companies seeking to determine levels of metal contaminants in drug manufacturing or beneficial metals or their compounds that are required in certain drugs use ICP- OES. UV-Vis instruments are used primarily for QA/QC of raw materials used in the manufacture of pharmaceuticals. The UV-Vis products are also used in conjunction with Varian VanKel dissolution testers used for measuring the bio-availability of active pharmaceutical compounds.
"Our 21 CFR 11-capable optical spectroscopy products complement Varian's gas and liquid chromatography instruments, which also allow customers to meet these regulations. In so doing, we are demonstrating a commitment to our pharmaceutical customers as they move their products through development, approval and into on- going manufacturing processes," said Garry Rogerson, senior vice president of Scientific Instruments, Varian, Inc.
The 21 CFR 11-capable software for Varian's SpectrAA AAS, Vista-PRO ICP-OES and Cary(R) 50, 100, 300 UV-Vis instruments as well as the 21 CFR 11 software for liquid and gas chromatography products are available for immediate delivery.
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Investigation with spectroscopy gives us unique insights into the composition and structure of materials. From UV-Vis spectroscopy to infrared and Raman spectroscopy to fluorescence and atomic absorption spectroscopy, spectroscopy offers us a wide range of analytical techniques to precisely characterize substances. Immerse yourself in the fascinating world of spectroscopy!
Topic World Spectroscopy
Investigation with spectroscopy gives us unique insights into the composition and structure of materials. From UV-Vis spectroscopy to infrared and Raman spectroscopy to fluorescence and atomic absorption spectroscopy, spectroscopy offers us a wide range of analytical techniques to precisely characterize substances. Immerse yourself in the fascinating world of spectroscopy!
Topic world Gas chromatography
Gas chromatography is an essential method in analytical chemistry for the separation and analysis of volatile compounds. Due to its high resolution and sensitivity, it has become firmly established in areas such as environmental analysis, food chemistry or forensic science. GC provides precise and reliable results and enables deep insights into the chemical composition of samples.
Topic world Gas chromatography
Gas chromatography is an essential method in analytical chemistry for the separation and analysis of volatile compounds. Due to its high resolution and sensitivity, it has become firmly established in areas such as environmental analysis, food chemistry or forensic science. GC provides precise and reliable results and enables deep insights into the chemical composition of samples.
Topic World Chromatography
Chromatography enables us to separate, identify and thus understand complex substances. Whether in the food industry, pharmaceutical research or environmental analysis - chromatography opens up a treasure trove of information about the composition and quality of our samples. Discover the fascinating world of chromatography!
Topic World Chromatography
Chromatography enables us to separate, identify and thus understand complex substances. Whether in the food industry, pharmaceutical research or environmental analysis - chromatography opens up a treasure trove of information about the composition and quality of our samples. Discover the fascinating world of chromatography!