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.
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 T: +44 1477 539 539 F: +44 1477 539 540 E: gxp[.]scottpr.com.