PerkinElmer Introduces PYRIS Enhanced Security Software

Streamlines Regulatory Compliance for the Pharmaceutical Industry

SHELTON, Conn. – PerkinElmer Instruments introduces the new PYRIS™ Enhanced Security Software that enables 21 CFR Part 11 technical regulatory compliance. The software works in conjunction with the PYRIS TA Manager Software - the engine behind PerkinElmer's thermal analysis techniques. The Enhanced Security option assists users in both research and quality control to meet the Food and Drug Administration's (FDA) 21 CFR Part 11 regulations.

Key features of the PYRIS Enhanced Security Software are user level management, file protection, audit trails, and electronic signatures. The electronic signature capability is integrated into the software, providing customers with a complete package from a single source. The PerkinElmer PYRIS Enhanced Security option is fully compatible with instruments running on the PYRIS software platform, allowing both new and existing customers access to the benefits of Enhanced Security.

"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."

PYRIS Enhanced Security Software combines the power of the Windowsâ operating system with your laboratory's network to provide improved performance for all analytical techniques. The software is developed and structurally validated following a certified quality system that conforms to Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and ISO 9001 guidelines. Our software development life cycle also conforms to the ISO-9000-3 and IEEE guidelines. As part of the solution, PerkinElmer offers Installation Qualification (IQ) and Operational Qualification (OQ) services and can assist with Performance Qualification (PQ), if required.

About PerkinElmer Instruments
PerkinElmer Instruments, an advanced technology company, provides application-specific analytical solutions for the pharmaceutical, food and beverage, environmental, chemical, and semiconductor industries. Applying technologies such as spectroscopy, chromatography, thermal analysis, and informatics, PerkinElmer Instruments provides systems that identify and quantify chemicals, materials, and biochemicals. With locations in over 129 countries, PerkinElmer Instruments is committed to high-quality, global customer service. For more information, please visit the company's Web site at www.perkinelmer.com/instruments

PerkinElmer is a trademark of PerkinElmer, Inc.
PYRIS is a trademark of PerkinElmer Instruments LLC.
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