Skye Biologics increases production throughput by 35%.

1The challenge.

Skye Biologics manufactures BioECM® allografts from donated placental tissue. It is a multi-step process in which every unit traces back to a specific donor and must meet FDA requirements for human tissue products.

Manufacturing was paper-based. Batch records were handwritten. Tracing a finished allograft back through each processing step to the original donor tissue meant pulling physical records and cross-referencing them by hand. When yield dropped on a production run, finding the cause meant searching paper records across several process steps.

The team knew rework rates were higher than they should be, but without queryable data it could not pinpoint which steps were responsible. Audit preparation took days of assembling documentation, and each new product variant meant copying paper templates and checking that nothing had been missed.

2What changed.

Skye evaluated several vendors and chose Seal because one platform covered the full scope: document control, training, batch records, supplier management, inventory, environmental monitoring and instrument integration.

Batch records moved from paper to guided digital steps. Operators follow the same process on screen, and each weight, measurement and observation is captured as it happens. Seal records every donor tissue lot through each processing step to each finished unit, so lot genealogy no longer needs manual cross-referencing.

Environmental monitoring data comes from the instruments into Seal. Temperature excursions, particle counts and microbial results are linked to the batches produced under those conditions, so when an alert is raised the affected batches are already identified.

Labelling, previously handled in a separate tool, moved onto the same platform. Labels are generated from batch data, which removes the transcription step between the batch record and the label printer.

3The outcome.

Production throughput rose by 35%, with gains from places the team had not expected. Moving labelling into Seal retired a separate tool and its manual steps. Batch record data showed which process steps drove rework, so the team could fix them. Live production status replaced the daily meetings in which supervisors pieced together progress from paper records.

Non-conformances fell by 40% and procedure review cycles became twice as fast. The controls sit in the workflow: training is checked before execution, procedures are used at the current version, and deviations are linked to CAPAs.

Lot genealogy, from donor tissue to finished allograft, is a query in the system rather than a manual reconstruction, so questions from customers or regulators about a specific unit can be answered from the record.