hVIVO operates a single Quality Management System to ensure compliance with GCP regulations and guidelines –including the UK Statutory Instruments, European Directives, ICH and many more. The Quality Management System encompasses all activities that influence quality including audit, documentation, a corrective and preventive action (CAPA) system, supplier management, quality control, validation, risk management and training. The Quality Management System is overseen by the Regulatory and Quality Governance Department consisting of senior quality and regulatory professionals who are active within the following professional organisations; TOPRA, RQA, HSRAA.
- The hVIVO Independent Quality Assurance function implements a structured internal audit program and the Quality Assurance function itself is subject to annual independent audit
- The Regulatory and Quality Group also includes management of a regulatory archive facility who are responsible for all data at the end of a study and management of the electronic document management system QuMas
- A dedicated Regulatory Affairs team provide regulatory support across the company and manage clinical trial applications
hVIVO provides an environment where all employees are suitably trained and competent in their defined scope of work and can contribute freely to the continual improvement and implementation of new and enhanced systems to help improve service, effectiveness of the quality management system, client experience and the final product of hVIVO.
Quality objectives are clearly defined in alignment with the company’s corporate targets and goals, and these are communicated and understood within the organisation. The objectives are reviewed on a regular and frequent basis to improve the effectiveness and efficiency of the business.
All Clinical trials and clinical support laboratory work is conducted in accordance with Good Clinical Practice regulations, required European Directives, UK Statutory Instruments and ICH GCP guidance documents.
hVIVO has been inspected by the Medicines and Healthcare Products Regulatory Agency (MHRA) as part of their routine inspection programmes for GCP and GCP For Laboratories.
hVIVO hold a Human Tissue Authority (HTA) licence for research and have been inspected by the HTA.
hVIVO Governance of Clinical Staff
Responsible Officer and Designated Body status
Our Responsible Officer (Dr Martin Johnson) has delegated authority from NHS England (and ultimately the General Medical Council) to ensure the systematic assessment of Physicians operating at hVIVO, and to validate that they are safe and competent to operate on a continuing basis in their medical capacity. Dr Johnson acts as the recognised approver for the revalidation of Physicians working within hVIVO.
Responsible Officers have an important statutory role in medical regulation to ensure the continuing ability for medical practitioners to remain in practice. Dr Johnson is responsible for the successful implementation of revalidation of Physicians at hVIVO – this is of course key to the safety of our volunteers, and to provide in-house assessment of our Physicians on a regular and systematic basis.
As a Responsible Officer, Martin is accountable for the local clinical governance processes within our ‘healthcare organisation’, focusing on the conduct and performance of Physicians. His duties in this important capacity include evaluating a Physician’s fitness to practise, and liaising with the GMC over relevant procedures.
hVIVO is a “Designated Body”
What is a Designated Body? Most licensed physicians have a connection with one organisation that provides them with an annual appraisal and helps them with revalidation. This organisation is called a ‘Designated Body’. Only UK organisations can be Designated Bodies, because the legal rules that determine this only cover the UK.
What is a Designated Body’s role? Physicians are supported with appraisal and revalidation working in an environment that monitors and improves the safety and quality of their care and service delivery, regardless of how or where the Physician practises in the UK.
It is the Responsible Officer of this Designated Body who makes a recommendation about each Physician, every five years, to recommend that each is up to date, remains fit to practise and should be revalidated.
GMC (General Medical Council)
The General Medical Council’s (GMC) register contains details of more than 270,000 doctors, including when and where they qualified, whether they hold a licence to practise and whether they are subject to any restrictions. hVIVO uses the GMC register to carry out pre-employment checks, making sure the doctors we employ are registered and have a licence to practise in the UK.
Recently updated to reflect changes in the GMC’s responsibilities, the register includes:
- Doctors in training – the register now identifies whether the doctor is in GMC-approved training programmes and the specialty in which he or she is training.
- The name of each doctor’s Responsible Officer and the Designated Body which is responsible for the Revalidation of their licence
- New information about doctors has been added to the General Medical Council’s (GMC) register, making it more informative.
- Approved GP trainers – identifying which doctors are GMC-approved Trainers of doctors undergoing GP training.
Nursing and Midwifery Council (NMC)
The Nursing and Midwifery Council is the professional regulatory body for nurses and midwives in the UK. Its role is to protect patients and the public through efficient and effective regulation. Revalidation for nurses is a process that allows nurses to maintain their professional registration and demonstrate continued ability to practice safely and effectively. It is a continuous process, including a recommendation once every 3 years to enable registration renewal. hVIVO only employs nursing staff registered on the NMC register and also provides support for nursing staff with regard to professional development and revalidation.
Nominated body for Pharmaceutical Medical Specialty Trainees
hVIVO is also a nominated training body for Pharmaceutical Medical Specialty Trainees with the Academy of Pharmaceutical Medicine. This provides a training environment for any Physician that has chosen to specialise in Pharmaceutical Medicine, through regular assessment, further academic study and educational supervision.