Global leader in analytical solutions releases new software suite for
pharma lab instruments to simplify technical compliance with USFDA 21
CFR Part 11 regulations
WALTHAM, Mass.--(BUSINESS WIRE)--
Inc., a global leader focused on improving the health and safety of
people and the environment, today announced the introduction of the new
NexION® Enhanced Security™ (ES) Software, to streamline
regulatory compliance by pharmaceutical companies. The ES Software
platform was developed for users of PerkinElmer's
NexION 300 ICP-MS system.
As regulatory compliance is a complex, ongoing and exacting process, the
NexION ES Software platform ensures the integrity of electronic data
records that are generated under industry-standard protocols within
pharma research and QA/QC organizations. It was designed to enable
researchers and quality control professionals to meet U.S. Food and Drug
Administration (FDA) 21 CFR Part 11 regulations through key
compliance-centric features. The software platform enables NexION
customers to have confidence that their compliance needs are being met
while maintaining high productivity.
The NexION ES Software provides user level management, file protection,
and audit trails and 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. The
system provides technical compliance in terms of software development
and data integrity, with security features that help create a secure,
The NexION ES Software option is fully compatible with all NexION 300
ICP-MS instruments, allowing both new and existing customers access to
the benefits of Enhanced Security. The software platform's development
life cycle also conforms to the ISO-9000-3 and IEEE guidelines and
combines the power of the Microsoft® Windows® 7
operating system with that of laboratory networks to provide improved
performance for all analytical techniques.
As part of the solution, PerkinElmer offers Installation Qualification
(IQ) and Operational Qualification (OQ) services and can assist with
Performance Qualification (PQ) to support customers' quality management
About PerkinElmer, Inc.
PerkinElmer, Inc. is a global leader focused on improving the health and
safety of people and the environment. The Company reported revenue of
approximately $1.7 billion in 2010, has about 6,200 employees serving
customers in more than 150 countries, and is a component of the S&P 500
Index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Edelman (On behalf of PerkinElmer, Inc.)
Amanda L. Connolly,
Source: PerkinElmer, Inc.
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