Our Clinical trials and clinical support laboratory work is conducted in accordance with GCP regulations and guidelines (UK Statutory Instrument 2004/1031 and subsequent amendments, European Directives and ICH GCP E6(R2).
We recognise that the provision of a quality service is both critical to the growth, success and reputation of our business and of that of our clients. Our organisation operates and maintains high quality standards which is underpinned by a robust, embedded and effective Quality Management System. Quality and the maintenance of high standards are the collective responsibility of all hVIVO colleagues with quality being achieved by the commitment and dedication of everyone.
Our Quality Management System overseen by Regulatory and Quality Governance Department and encompasses activities that influence quality across our organisation namely:
- Risk-based Audit Programme – Value adding, focussed, flexible and adapting audit programme that readily identifies quality and compliance risks and trends. Also providing project support with trial specific audits
- CAPA System – A system that delivers timely corrective/ preventative process and effectiveness reviews
- Supplier/ Vendor Management – Risk-based Supplier/ Vendor Management programme ensuring appropriate oversight of third parties
- Validation – Assuring that systems have undergone appropriate validation as well as providing oversight/ guidance in support of validation activities across the business
- Training – Delivery of Regulatory training across the business
- Document Control – hVIVO uses fully validated ‘QUMAS’ electronic document management system
hVIVO have undergone inspection by the Medicines and Healthcare Products Regulatory Agency (MHRA) as part of their routine inspection programmes for both GCP and GCP for Laboratories as well as inspection by the Human Tissue Authority (HTA) and hold a Human Tissue Authority Licence for research.