Bioventix cuts document admin time by 80%.

1The challenge.

Bioventix’s antibodies run on diagnostic analysers in hospitals worldwide. The company has operated under ISO 9001 and ISO 13485 since 2003 and is regularly audited by the diagnostic companies that depend on its antibodies.

For over two decades the quality system ran on paper: procedures in Word documents, handwritten lab records and completed documents stored in hard copy. The system was mature, it worked, and the team knew how to use it.

But more than twenty years of paper records had become a physical problem. Storage space was running out. Retrieving historical data meant searching binders. As production grew, document administration crowded out scientific work. Paper also offered no protection against loss or damage: a single incident could destroy years of data.

The challenge was specific to Bioventix’s size. It is a small, highly integrated company with a QMS that works, and it needed that system digitised without changing the processes that had served it for years.

2What changed.

Alison Reynolds, Quality Manager for over 14 years, led the search with Harry Carter, Purification Scientist. They needed one platform for both the QMS and lab notebooks. The vendors they evaluated offered one or the other, and none offered both with the flexibility to keep Bioventix’s existing processes.

Seal met that requirement. The team moved its QMS (document control, training, audits and CAPAs) and its lab records onto one platform. The procedure structure, approval workflows and training requirements stayed as they were. What changed was the medium: paper became electronic records, manual tracking became system tracking, and quality events linked to their source data.

Lab records gained auto-calculations and entry validation. When Harry’s team runs purification processes, calculations are made by the system and entries outside expected ranges are flagged, replacing manual entry and hand-checking.

3The outcome.

Document admin time fell by 80%. The revision, approval and training cycle that used to need manual coordination now runs through structured workflows, so the quality team spends its time on quality decisions rather than document logistics.

With process data captured in structured form, the purification team built its own analysis on top. “We can easily analyze our data using custom python code, allowing us to share visualisations with our colleagues to better monitor our internal processes,” says Harry Carter. Yield trends and process parameter correlations that were impractical to extract from paper now inform continuous improvement.

External confirmation came from a customer audit, which produced positive comments specifically on the electronic signatures and audit trails. For a supplier to global diagnostic companies, that external view carries weight.