Samples

Complete sample lifecycle management for pharmaceutical manufacturing. Every sample tracked from collection to disposition. Every test optimised. Every stability pull on schedule.

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Built for Complete Sample Traceability

Every sample tracked from collection through testing, review, and disposition, with complete chain-of-custody and AI-optimised scheduling.

Leucine Samples manages the full sample lifecycle from collection to disposition. MES triggers in-process sampling at the right batch execution step. Samples are tracked with barcode-driven chain-of-custody through storage, testing, and review. AI optimises test scheduling based on priority, analyst availability, and instrument capacity. And when OOS results are detected, deviations are triggered automatically in the Deviations app with full sample context.

Full Sample Lifecycle

Track every sample from collection through login, storage, testing, review, and disposition, with complete chain-of-custody and barcode-driven identification at every handoff.

Sample Login.

Barcode-driven sample login with automatic label generation, storage location assignment, and sample plan verification against batch requirements.

Chain-of-Custody.

Every sample handoff, from collection to transport, storage, retrieval, testing, and disposition, is recorded with user identity, timestamp, and location.

Storage Management.

Sample storage locations are tracked with capacity monitoring, condition verification, and automated alerts when storage conditions deviate.

Disposition Workflows.

Sample disposition decisions are documented with electronic signatures, linking final status to test results, specifications, and reviewer approval.

AI-Optimised Test Scheduling

AI schedules tests based on sample priority, analyst qualifications, instrument availability, and turnaround requirements, maximising lab throughput while meeting release timelines.

Priority-Based Scheduling.

Samples are scheduled based on batch release urgency, stability pull dates, and regulatory submission timelines, critical samples are fast-tracked automatically.

Analyst Workload Balancing.

AI distributes tests across qualified analysts based on current workload, shift schedules, and method-specific certifications.

Instrument Availability.

Test scheduling accounts for instrument calibration schedules, maintenance windows, and current utilisation, avoiding bottlenecks and idle time.

Turnaround Optimisation.

AI minimises overall turnaround time by identifying parallel testing opportunities and sequencing dependent tests for maximum throughput.

Stability Program Management

Manage stability studies with automated pull schedules, condition monitoring, and shelf-life predictions, from protocol creation through final reporting.

Study Protocol Management.

Define stability study protocols with pull points, test requirements, storage conditions, and acceptance criteria, version-controlled and audit-trailed.

Automated Pull Schedules.

Pull schedules are generated automatically from the study protocol, with reminders sent to lab personnel ahead of each pull point.

Condition Monitoring.

Stability chamber conditions are monitored continuously with excursion alerts, linked to the Environment app for full environmental traceability.

Shelf-Life Prediction.

Statistical models predict shelf-life from interim stability data, providing early indication of whether products will meet their target expiry.

Smart Disposition & OOS Handling

AI evaluates test results against specifications and historical data to recommend disposition, and when OOS results are detected, deviations are triggered automatically with full sample context.

Specification Evaluation.

Test results are compared automatically against product specifications, compendial limits, and in-house standards, with pass/fail determination and trend flagging.

OOS/OOT Detection.

Out-of-specification and out-of-trend results are flagged immediately, triggering investigation workflows before disposition decisions are made.

Disposition Recommendations.

AI recommends sample disposition based on test results, specification compliance, historical batch data, and any associated deviations or investigations.