Autoscribe Publishes New Medical Devices Case Study

Autoscribe Informatics has just released a new case study in conjunction with Swiss Precision Diagnostics (SPD) who have replaced their legacy Laboratory Information Management System (LIMS) with Matrix Gemini. The new LIMS integrates data from volunteer sample collection, laboratory testing and a clinical biobank to provide integrated data management across their organization.

Swiss Precision Diagnostics (SPD) is a leading supplier of home pregnancy and fertility/ovulation tests. Formed in 2007 SPD employs around 200 people in its Geneva Switzerland headquarters and at the Clearblue Innovation Centre in Bedford, UK. The Company’s products are regulated under the European In-Vitro Diagnostics (IVD) Directive 98/79/EC, and in the USA by the Food and Drug Administration (FDA) under CFR, Title 21, Part 809 and it is certified to ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.

Tight regulatory requirements in SPD’s worldwide markets means that traceability of data is key. The Clearblue Innovation Centre in the UK is responsible for R&D and testing activities to ensure that the tests work as expected. To do this the SPD team in Bedford take samples from volunteers and, after aliquoting, stores those samples in a clinical biobank. Depending on the study being undertaken selected samples are tested and the results reported. The clinical biobank has grown to over 500,000 specimens stored in thirty-nine -80° freezers and continues to grow month by month.

The flexible nature of Matrix Gemini allows simple configuration of the system to meet SPD’s needs. “The graphical approach is straight forward to use and it can cope with SPD’s unique and varied requirements”, noted the Clinical Laboratories Manager. “The biggest strength of Matrix Gemini is its flexibility. Whilst the basic structure of the LIMS is very stable, we found that screens within the workflow can be very quickly optimized to make our lives easier. We have been able to tailor the system to our exact needs rather than the other way round. On top of this the ease of use has made it easier for the team to understand and adopt.”

“The SPD solution encapsulates all their needs into one integrated solution and personifies how a flexible LIMS solution can be adapted to suit the needs of any laboratory,” said Tim Daniels, Marketing Manager at Autoscribe Informatics. “The graphical workflows within Matrix Gemini are easily modified to individual customer needs. When you spend all day using a LIMS it makes a big difference that the LIMS ‘bends’ to your internal processes and is straight forward to use.”

The case study can be downloaded here: