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
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PALO ALTO, Calif., Jun 18, 2002 Varian, Inc. recently introduced its ICP Expert 21 CFR 11 software, which assists users of its Vista-PRO ICP-OES (inductively coupled plasma-optical emission spectroscopy) instruments to achieve compliance with the important U.S. FDA 21 CFR 11 regulation. With this software, the Vista-PRO ICP-OES joins other Varian optical spectroscopy products, specifically the SpectrAA series AA (atomic absorption) and Cary(R) 50, 100, 300 UV-Vis (ultra-violet - visible) instruments in providing pharmaceutical laboratories with full method and data security and electronic signature capability. Varian, Inc.'s liquid chromatography and gas chromatography instruments also assist users to become compliant with the 21 CFR 11 regulation.
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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