Assisted Conception Units CQV
Supporting Assisted Conception Units with Validation & Qualification
-
15+ years
-
UK Wide
-
HFEA
Assisted Conception Units play a critical role in fulfilling the dreams of patients struggling with fertility issues. However, these facilities must adhere to stringent regulatory guidelines to ensure the safety and efficacy of assisted reproduction procedures. At Validair, we recognise the importance of validation and qualification in this field, helping Assisted Conception Units to maintain the highest standards of quality and compliance.
Background to the projects
Validair has been at the forefront of providing validation and qualification support to Assisted Conception Units (ACUs) across the country in this challenging medical sector for over 15 years. While the expertise Validair has delivered in supporting Fertility Centres speaks for itself among those involved in our projects, we want to showcase the important role we play. Validair prepares and delivers essential protocols to ensure successful inspection by the Human Fertilisation and Embryology Authority (HFEA).
In this challenging sector, a commitment to excellence at every level is essential. There are, quite literally, new lives at stake. Our commitment extends beyond simply delivering critical validation documentation. We have worked closely with the Association of Clinical Embryologists (ACE) along with regulatory bodies such as the HFEA to ensure that ACUs are well- equipped for successful inspections. In turn, we know that such regulatory approval leads to better outcomes for the clinics and practices.
Project scope
The Validair team has demonstrated its expertise in the field by supporting a range of ACUs across the length and breadth of the country. Our client list includes notable establishments such as Glasgow Royal Fertility Centre, Bourn Hall Fertility Clinics, Manchester Fertility, King’s Fertility London, Wales Fertility, Royal Hallamshire Hospital Jessop Fertility, and Hewitt Fertility Centre.
In 2021, the Validair team supported Hull and East Riding Fertility to deliver a brand-new facility offering IVF, ICSI, and Andrology services. Our work provided comprehensive support for the duration of the facility’s establishment process. Validair’s services encompassed everything from the initial detailed design review to installation qualification and operational qualification. The new facility passed its HFEA inspection with flying colours.
Where it started
The valuable Validair partnership with the ACE resulted in the development of a comprehensive Validation Guidance Platform that leads Assisted Conception Units from the initial stages of creating URS documents and Validation Plans to delivering robust Process Validation through a series of templates. Process Validation demonstrates effective monitoring, verification, and control of the processes involved in assisted conception treatments.
This guidance model along with our extensive experience in providing validation and qualification support to ACUs has proven invaluable across the UK. Our recent collaboration with Hull and East Riding Fertility highlights a commitment to the highest standards of quality and compliance that the management teams and clinicians at these innovative facilities want to see.
Where does it end?
It doesn’t. Individuals seeking support with their fertility are increasingly turning to Fertility Centres as reproduction treatments and technologies evolve and clinics strive for excellence to increase the likelihood of successful outcomes. For our part, Validair remains a dependable partner, providing the industry-leading validation and qualification support that these respected facilities need.
