Royal Wolverhampton NHS Trust validate their Q-Pulse software in line with ISO 15189 requirements
As thorough and experienced users of Q-Pulse since 2004, the software, from Ideagen, had become of vital importance to Royal Wolverhampton NHS Trust’s Pathology department and had helped simplify the tasks associated with its compliance efforts. Indeed, Q-Pulse played a key role in achieving and maintaining compliance to ISO 15189 and meeting strict criteria laid down by regulatory bodies such as MHRA, HTA, CQC and HSE.
It was during the transition from CPA to ISO 15189, however, that the Trust’s Pathology department realised that they had to address an issue regarding documented evidence for the validation of its Q-Pulse system. In order to successfully achieve certification to ISO 15189, documented evidence for Q-Pulse had to exist and be made available for assessors. In short, to achieve this documented evidence, the department would have to validate its entire Q-Pulse system – a potentially lengthy and painful operation.
Ideagen and CompliancePath, a Scottish-based expert in software validation services with over 20 years’ experience, offer a Q-Pulse validation pack to customers who require the software to be validated against a specific standard or set of standards. The pack assists organisations – such as the Royal Wolverhampton NHS Trust – by touching on each Q-Pulse module in depth and providing a simple guide to follow for successful validation.
Benefits
- Easy to follow validation package offers a step-by-step guide to validation of Q-Pulse – removing potentially months from the validation period
- Quick certification to ISO 15189, reducing the impact on the Pathology department and quality management levels in general
- Significant savings on associated staffing costs
- Validation Pack covers all Q-Pulse modules in detail, leaving no stone unturned during validation
- “Fantastic” and “hassle-free” service by both Ideagen and CompliancePath – removing a “major headache” for the Pathology department
"The main benefit from the pack was the huge savings in time which would have been spent validating the system ourselves. We also saved on associated staffing costs that would have been incurred, which is often forgotten about."
