New PerkinElmer FT-IR Software Streamlines Regulatory Compliance

06-Feb-2002

The new Spectrum Enhanced Security software that enables 21 CFR Part 11 technical regulatory compliance for the pharmaceutical industry is now available for PerkinElmer FT-IR Instruments. The software assists pharmaceutical organizations in meeting the requirements of the FDA's 21 CFR Part 11 regulations.

"We are committed to developing tools to help customers achieve compliance with the mandates included in 21 CFR Part 11," said David Spaight, vice president of global sales and service for PerkinElmer Instruments. "The company has invested heavily in software development efforts to achieve technical compliance across all product lines. This company-wide effort leverages our extensive market expertise and allows us to work with pharmaceutical and other regulated industries to help them understand and comply with these complex regulations."

Spectrum Enhanced Security meets pharmaceutical companies' need to ensure the integrity of electronic data records that are generated under Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) protocols. The system provides technical compliance in terms of software development and data integrity, with extra security features that help quality assurance (QA) and regulatory compliance managers create a secure, reliable environment. Spectrum Enhanced Security software also provides secure login using a combination of Windows NT® and Spectrum features, to ensure that data cannot be generated without permitted access to the system.

The software is available for new and existing Spectrum One and Spectrum One NTS FT-IR systems. It is also an integral part of the AssureID software solution suite, the component that assists pharmaceutical manufacturers in streamlining internal processes and reducing costs. As part of the solution, PerkinElmer offers Installation Qualification (IQ) and Operational Qualification (OQ) services and can assist with Performance Qualification (PQ), if required.

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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!

70+ products
40+ whitepaper
60+ brochures