GXP Consulting has announced the addition of extended Computer Systems Validation (CSV) services to its portfolio.
The extended portfolio of services together with the 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 organisation.
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.
The expanded CSV service from GXP enables companies to implement the necessary controls to meet strict regulatory requirements, including risk assessment, system validation, audit trails, the quality management system (QMS), software development lifecycle (SDLC), plus electronic signatures and documentation management for software and systems involved in processing and storing electronic data.
Headed by Mark Wright, the CSV team provides a full range of 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 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.
