Bioventix digitalise monoclonal antibody development with Seal, enhancing trust amongst ISO13485 regulated customers
About Bioventix
Bioventix is a biotechnology company that specialises in the development and production of high-affinity sheep monoclonal antibodies for use in immunodiagnostics. Their antibodies are used on blood-testing machines in hospitals and labs globally, powering the diagnosis and monitoring of cardiac disease, infertility, thyroid and other conditions. Bioventix is headquartered in Farnham, Surrey and has a small, dedicated team of 14 employees.
“A lot of the existing systems on the market seemed to be aimed at either enterprise scale or startups, we are neither of those.
We had a mature QMS and wanted it unchanged, but were seeking improved administrative efficiency, electronic signatures and audit trails.
Seal ticked all these boxes.” - Alison Reynolds, Quality Manager
Challenge
Since being founded in 2003, Bioventix have built and established a paper-based system across their quality and scientific systems.
Bioventix customers expect a high level of conformance to medical standards, Bioventix therefore operate a QMS based on ISO 9001:2015 and ISO 13485:2016. As a result, their processes and procedures are subject to regular audit both internally and externally from customers.
Their QMS had been established and maintained across a system of word documents and excel spreadsheets – with completed documents being stored in hard copy. This was starting to cause logistical concerns from a storage space point of view, it was also agreed that a switch to electronic data would provide improved protection from possible loss or degradation.
In addition, lab records were completed by hand – data was isolated to the paper record and, as the volume of data increased over time, this presented challenges when searching for and retrieving information. It had been agreed that an electronic lab notebook system would facilitate faster, easier and more accurate searches and analysis and give greater data security, as well as saving physical space.
Solution
The increasing trend to digitise data and the adoption of electronic systems across the industry prompted internal review and discussion. This was driven by a desire for greater efficiency, whilst maintaining compliance, to match increased business needs and the Bioventix team began to explore digital solutions.
The team agreed that a single solution to both quality and lab record management systems was the ideal product. However, they found that existing products serving the life science sector were for either one or the other and were not able to identify a single product that had the flexibility to offer solutions across both applications.
Alison Reynolds has served as the Quality Manager at Bioventix for over 14 years and led the search, alongside purification scientist lead Harry Carter, to ensure the selected solution best served the needs of every department.
As a small highly integrated organisation, the ability to incorporate both quality management and lab notes was a key requirement, as was the ability to migrate existing systems without changing underlying processes which had been working effectively for many years. With Seal, the team could unite and connect quality issues to their source, proactively pinpointing areas for improvement in their processes.
Results
1. Time savings of 80% through elimination of repetitive admin tasks
“Seal has significantly improved the speed of our document revision, approval and training processes. Activities are completed in a timelier manner and more time is available for other activities” - Alison Reynolds
Automated calculations and data verification checks reduce the manual and risk-prone burden on technicians in entering and checking data. Additional automations have been incorporated, including labelling automation and data analysis tools.
“The incorporation of auto-calculations, entry validation, review requests and comprehensive audit trail has greatly improved the efficiency and traceability of our processes” - Harry Carter, Purification Scientist
2. Trust amongst customers
Bioventix have received “several positive comments on electronic signatures and audit trails within the system following a recent customer audit.”
3. Cutting paperwork and boosting traceability
Bioventix have digitalised their QMS and lab records, eliminating the need for physical storage space and massively improving their ability to access, retrieve and utilise their documentation and data.
4. Driving process improvements with data
With data captured from their processes, Bioventix can more easily identify bottlenecks and make changes, fostering a culture of continuous improvements backed by data.
“We can easily analyse our data using custom python code, allowing us to share visualisations with our colleagues to better monitor our internal processes” - Harry Carter, Purification Scientist
5. Ongoing, hands-on partnership
Bioventix benefit from ongoing support with their partnership with Seal, whether it’s in the regular provision of new updates and changes, the exploration of new feature requests, or the implementation of new digital systems. For example, the team were interested in incorporating automated labels onto their solution batches. Support from Seal’s implementation consultants helped to make it happen.