The sample that couldn't be used.

Three years into a longitudinal study, a researcher requested samples from the 2021 cohort. The samples existed—frozen at -80°C since collection. But the consent form from 2021 only covered the original study. The new use wasn't permitted. 500 samples, meticulously collected and stored, unusable for the research that needed them.

Biobanking isn't just freezer management. It's ensuring samples remain scientifically valid AND ethically usable for their entire storage life.

Collection with complete provenance

A sample's value comes from its documentation. When was it collected? From whom? Under what protocol? With what consent? Using what technique?

Seal captures provenance at collection. Patient/donor identifier, collection protocol, collection site, collector, time, conditions. Consent documents link to the sample. When someone uses this sample in ten years, they know exactly what they're working with.

Consent management for the long term

Consent forms aren't static. Studies evolve. New uses emerge. Regulations change. GDPR created new requirements for existing samples.

Seal tracks consent at granular level. What was consented? Genetic analysis? Commercial use? Return of results? When consent is withdrawn, affected samples are flagged. When new uses are proposed, you can query which samples have appropriate consent.

Reconsent campaigns? The system identifies which donors need to be contacted and tracks response.

Storage that maintains integrity

-80°C freezers. Liquid nitrogen tanks. Ambient archives. Each has monitoring requirements, each has failure modes.

Seal tracks storage locations and conditions. Freezer mapping shows exactly where each sample lives—shelf, rack, box, position. Temperature monitoring integrates with alerting. If a freezer fails, you know immediately which samples were affected and for how long.

Chain of custody logs every time a sample moves. Remove from freezer for aliquoting—logged. Return to storage—logged. Ship to collaborator—logged with transport conditions.

Sample requests and fulfillment

A researcher requests samples meeting specific criteria. Demographics, diagnosis, collection timepoint, consent coverage, available volume.

Seal queries the repository. Here are 234 samples meeting your criteria. Review, select, approve. The system generates pick lists, tracks retrieval, logs shipping, and decrements inventory.

When samples go out, they're tracked. What was shipped, to whom, for what study, with what agreement. If results come back, they link to sample records.

Aliquoting and derivatives

The original sample is precious. You don't send the whole thing. You aliquot—create derivatives that link to the parent.

Seal tracks parent-child relationships. The original blood draw produces serum aliquots, plasma aliquots, PBMC vials. Each derivative inherits provenance from the parent. Use one aliquot, the others remain. Track concentration, volume, number of freeze-thaw cycles.

Quality and viability

Samples degrade. Storage conditions matter. Freeze-thaw cycles matter. How do you know if a sample is still usable?

Seal tracks quality indicators. Storage history, temperature excursions, freeze-thaw count. Quality testing results—DNA integrity, cell viability, protein concentration. When a researcher requests samples, they see quality metrics alongside availability.

Samples that don't meet quality thresholds can be flagged or retired from the available pool.

Regulatory compliance

CLIA, CAP, ISO 20387, ISBER best practices. Biobanks operate under regulatory frameworks that require documentation, quality management, and personnel qualification.

Seal provides the quality system for biobank operations. SOPs, training records, equipment qualification, proficiency testing. When inspectors audit your biobank, the documentation exists in one system.

ISO 20387 certification requires demonstrating your biorepository meets international standards for sample quality, traceability, and management. Seal generates the documentation package auditors need: collection protocols, processing SOPs, storage monitoring records, personnel competency evidence, and complete sample histories. The gap analysis happens before the audit, not during it.

For clinical biobanks operating under CLIA, sample processing must follow validated procedures with appropriate quality controls. Seal tracks method validation, quality control results, and proficiency testing performance. When CAP inspectors review your operations, they see a unified quality system—not scattered documentation across spreadsheets and file servers.

De-identification and privacy

Research samples often require de-identification to protect donor privacy while preserving scientific utility. But "de-identified" isn't binary—it's a spectrum from fully identified to completely anonymized, with pseudonymization in between.

Seal manages the identity layer separately from the sample data. Researchers see study codes, not names. The link between code and identity exists in a controlled vault with restricted access. When a researcher needs to correlate samples with clinical outcomes, the system can perform the linkage without exposing identifiable information to the researcher.

Re-identification is sometimes necessary—return of results, consent updates, follow-up collections. The system controls who can re-identify samples and logs every access. When GDPR or HIPAA requires demonstrating privacy controls, you can show exactly who accessed identifiable data and why.

Honest brokers—neutral parties who manage the link between identities and research codes—can operate within Seal. The honest broker sees the mapping; researchers see only de-identified data. The architecture enforces the separation that your IRB requires.

Sample lifecycle and retirement

Samples don't live forever. Consent expires. Quality degrades. Storage costs accumulate. Retention periods end.

Seal tracks lifecycle milestones. Consent expiration dates surface for review—extend, reconsent, or dispose. Quality thresholds trigger retirement from the available pool. Retention period completion flags samples for disposition review.

Destruction workflows document what was destroyed, when, how, by whom, with witness signatures where required. The sample record persists—you can always answer "what happened to sample X?"—but the physical sample and its data are handled according to protocol.

For samples with specific retention requirements (clinical trials, regulatory holds), the system prevents premature destruction. The hold releases only when authorized. No accidental disposal of samples you're legally required to keep.

Integration with research systems

Samples exist to support research. Seal integrates with laboratory systems where analysis happens, with clinical systems where patients are treated, with research databases where results accumulate.

When a sample is analyzed, results link back. When a publication uses your samples, the citation links to sample records. The repository becomes a knowledge base, not just a freezer inventory.

Publication tracking closes the loop. When researchers publish using your samples, link the citation to the sample records. Generate impact reports showing how many publications, which journals, what research areas. Demonstrate the value your biorepository provides to funders and institutions. Every grant application can include concrete evidence of sample utilization and scientific output.