| Measure | Result |
|---|---|
| Documentation time | −75% |
| Traceability | Instant lot genealogy |
| Scale | Lab to commercial on one platform |
1The challenge.
MiAlgae was scaling production of omega-3-rich algae from the laboratory to commercial volumes. The science worked. The documentation behind it had not kept pace.
Processes were documented on paper. Batch records were handwritten, lab notebooks were physical and quality events were tracked in spreadsheets. Every hour spent on documentation was an hour taken from the science.
Speed was only part of the problem. When a customer asked for traceability from raw material to final product, the answer meant pulling physical records from several locations. When the quality team wanted to understand why a batch underperformed, the data existed but could not be queried.
As production volumes grew, paper systems that had worked at bench scale began to strain. Batch records took longer to complete, review cycles stretched, and the gap widened with every new production run.
2What changed.
MiAlgae adopted Seal as one platform for its ELN, QMS and electronic batch records, replacing three separate documentation routes with one connected system.
Scientists moved from paper notebooks to structured digital protocols. The same experiments were now captured in a form that could be searched, compared and extended. A process developer looking for every fermentation run above a yield threshold could run a query instead of searching binders.
Batch records moved on screen. Operators follow guided steps instead of paper forms, and the record fills in as the work happens: weights from balances, readings from instruments and timestamps from the system. Review shifted from checking every handwritten entry to reviewing the exceptions the record flags.
Deviations, CAPAs, document control and training moved onto the same platform. A deviation raised during a batch links to the batch record, the operator’s training status and the procedure version in use, so the investigation starts with that context already attached.
3The outcome.
Documentation time fell by 75%. Hours that scientists and operators had spent writing, filing and retrieving paper records went back to productive work.
Lot genealogy is now available from the system. The forward and backward traces customers ask for, from raw material lot to fermentation batch to final product, no longer depend on assembling physical records.
With documentation easier, the team began capturing more of it. Process observations that would not have made it into a paper notebook are recorded, building a dataset the team uses to improve the process.
MiAlgae has moved from laboratory work to commercial production on the same platform, without a second system or a second implementation project.
4From the team.
“Partnering with Seal has helped us build a more integrated quality system; digitizing workflows, improving traceability, and supporting the technical demands of a growing biotech company.”
“Seal has allowed us to seamlessly transfer our paper records to the platform with no disruption to the process, a very user-friendly system that has enhanced our capabilities.”
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