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GxP Consulting Extends Portfolio With Increased Computer
Systems Validation Services
Nottingham, UK, (May 11, 2009) - GxP Consulting, a
leading provider of compliance services to the pharmaceutical and
biopharmaceutical industries, today announces the addition of extended Computer
Systems Validation (CSV) services to its portfolio. The extended portfolio of
services together with the highly experienced GxP Consulting team can ensure GxP
compliance and adherence with FDA, EMEA, WHO, MHRA and Good Automated
Manufacturing Practice (GAMP) regulations.
Computer systems are an essential part of any pharmaceutical, biotechnology,
consumer healthcare, medical device, homeopathic and veterinary organization.
With the continuous evolution and increase of the regulatory requirements driven
by legislation such as FDA 21 CFR Part 11 Electronic Records, Electronic
Signature rule and industry standards such as the ISPE GAMP5 guidelines, there
is an ever-changing need to demonstrate compliance as efficiently and
cost-effectively as possible. Which are my GxP regulated computerized systems?
What are the risk to patient safety and product quality that need to managed?
What actually needs to be validated? The expanded CSV service from GxP enables
companies to implement the neccesary controls to meet these strict regulatory
requirements - including risk assessment, system validation, audit trails, the
quality management system (QMS), software development lifecycle (SDLC),
electronic signatures and documentation management for software and systems
involved in processing and storing electronic data.
Headed by highly experienced CSV consultant Mark Wright, the new CSV team
provides a full range of strategic consulting and tactical support service for
companies from CSV assessment and strategy building through to full development,
procurement, implementation, testing and validation of systems. The GxP
Consulting team has experience of successfully delivering projects to its
clients around the world and across the entire drug development lifecycle and
includes all areas of GXP compliance such as GLP, GCP, GMP, and GDP. The CSV
team offers regulatory inspection readiness, Clinical Trials Directive (CTD)
compliance, implementation and management of System Development Life Cycle (SDLC)
and CSV training services.
Mark Wright, Computer Systems Principal Consultant at GxP Consulting, said:
“There are ever increasing demands on the biopharmaceutical and pharmaceutical
industries to meet increasing regulatory and legislative requirements, whilst
improving the performance and efficiency of the business. With a wealth of
industry knowledge, we are ideally placed to not only provide regulatory
compliance services, but also to advise companies on optimal and most
cost-effective solutions.”
Headquartered in Nottingham, UK with offices in Irvine California, GxP
Consulting provides high quality, results-focused regulatory compliance services
to the highly regulated pharmaceutical and biopharmaceutical industries.
For more information on GxP Consulting, please call +44 (0) 115 924 8477 (EU) or
+1 949 725 2946 (US), email
enquiries@gxpEU.com or alternatively please visit
http://www.gxpEU.com
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About GxP Consulting
GxP Consulting provides businesses with high quality, results-focused
regulatory compliance (GMP, GAMP, GLP, GEP, GCP, GxP), qualified person (QP),
quality assurance (QA), consulting, project management, validation, process
development, computer systems, laboratory equipment, project management, design
studies, training and clinical technology consulting and contract services.
Specializing within the Biotechnology, Pharmaceutical, Consumer Healthcare,
Medical Devices, Homeopathic and Veterinary industries, GxP Consulting provides
a range of services to meet customer’s needs.
For further press information please contact: Celine Callender, The Scott
Partnership, 1 Whiteside, Station Road, Holmes Chapel, Cheshire CW4 8AA, United
Kingdom Tel: + 44 1477 539 539 Fax: +44 1477 539 540 E-mail:
gxp@scottpr.com
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