Case Study – InterSystems
InterSystems, a global technology leader, has focused on increasing its investment in its clinical programmes, including processes that support the DCB 0129 Safety Standard and identifying a full-time Clinical Safety Officer who engages with safety sponsors across the globe.
One of the challenges InterSystems faced was how best to undertake a safety assessment for concurrent projects, and optimise the management of artefacts such as the hazard log. InterSystems decided it urgently needed to reduce the process complexity without compromising assurance rigor. To help them achieve this goal they decided to augment the in-house safety team with independent expertise from Safehand.
Over a period of nine months, Safehand provided objective reviews and mentorship to the InterSystems Clinical Safety Officer and his team. The focus was on achieving repeatability, scalability and consistency for the safety programme. From the outset, the aim was to simplify and pare back. The language of the documentation was made accessible and pragmatic and the responsibilities of the supplier and customer were even more clearly defined.
The result was the formulation of pragmatic and concise safety deliverables for their InterSystems TrakCare® healthcare information system that provides millions of patients across the UK and in 24 other countries with a comprehensive electronic medical record. These deliverables empowered InterSystems’ customers to take an informed view on the product’s clinical risk profile and understand exactly what actions they needed to take to deploy the system safely.
Iain MacKenzie, Clinical Safety Officer for InterSystems commented, “InterSystems has always been passionate about the safety and effectiveness of its software. It is also serious about its duty to comply with clinical safety standards. I found working with Safehand easy, and by using structured document templates, we made faster progress. Safehand helped InterSystems interpret the standards, and define a compliant clinical safety system that is woven tightly into its overall business processes. There is no doubt in my mind that Safehand’s guidance helped us complete the work faster, and be even more thorough in our approach.”
InterSystems Clinical Risk Management strategy continues to grow, with priorities turning to the unification of safety processes across different continents. Adrian Stavert-Dobson, Managing Partner of Safehand commented, “It is immensely satisfying to sow the seed of ideas in an organisation and see them flourish. InterSystems have clear direction and commitment and are well on their way to becoming a shining light in proactive safety management.”