Quality events, deviations and complaints
Demonstrable foundationTyped event backbone, ownership, lifecycle, links and history.
In development
Life-science operations
Connect the evidence from quality event to authority decision.
Kelavon Life Sciences brings quality, regulatory, safety and operational work around shared product, organization and evidence records. Start with a focused workflow and extend without losing the history or context that made the original record meaningful.
Connected operating scenario
Complaint → safety assessment → signal → RMP action → change control → controlled document and training → regulatory commitment
This is the intended cross-domain operating model. The status matrix below does not imply that every step already runs as one released production workflow.
Capability status
Specific enough to evaluate. Honest enough to trust.
These labels describe current product evidence, not a release commitment. Commercial packaging, supported deployment and customer qualification remain separate gates.
Quality
Keep events, actions, evidence and effectiveness connected.
CAPA and effectiveness
Demonstrable foundationActions, accountability, lifecycle and effectiveness planning/checks.
GxP audits
Demonstrable foundationProgrammes, evidence requests, observations, findings, responses and closure.
Controlled documents and training
Demonstrable foundationDocument revisions, effectivity and exact-version training relationships.
Regulatory
Coordinate product, authorization, activity and commitment records.
Products, presentations and authorizations
Demonstrable foundationProduct, packaging, GTIN, storage, authorization lifecycle and renewal data.
Regulatory activities and commitments
Demonstrable foundationScope, changes, milestones, correspondence, evidence and due dates.
Submission control
In developmentSubmission records and content-placement foundation; deeper output control is incomplete.
Authority intelligence
Early-access scopeMonitoring and reviewed evidence through the Kelavon Monitor direction.
Live SPOR synchronization
External dependencyCSV reference import exists; live synchronization depends on credentials and verified integration.
Safety
Keep restricted cases, signals and risk decisions governed.
Safety case workspace
Early-access scopeRestricted cases, assessment, narrative, follow-up and quality handoffs.
Signals and risk-management plans
Early-access scopeSignal lifecycle, safety concerns, measures and retained governance.
Aggregate safety and PSMF
Early-access scopeGoverned report-data lock and oversight foundations; validated templates remain deployment-specific.
E2B exchange
External dependencyDraft foundation only; no claim of conformant gateway submission or licensed terminology coverage.
Manufacturing & Release
Connect batches, review evidence and controlled disposition.
Batch register and PQR
Demonstrable foundationBatch identity, product links, PQR lifecycle and compliance due dates.
Evidence-led batch review
Design-partner scopeQuestions, claims, evidence, gaps and superseding decisions through Kelavon Review.
Batch disposition and release
PlannedControlled disposition over quality and laboratory evidence remains future scope.
Recipes, execution, laboratory and stability
PlannedMaster batch records, execution, samples, OOS/OOT, stability and equipment are roadmap areas.
Supply & Distribution
Maintain control from planning to shipment, excursion and recall.
Pallet planning
Early-access scopeDeterministic carton and pallet planning through Kelavon Pallet.
Supplier qualification and quality agreements
PlannedSupplier/site qualification and agreement lifecycle remain roadmap scope.
Inventory, shipments and temperature control
PlannedLots, locations, lanes, monitors and excursion workflows remain planned.
Returns, recall, shortage and serialization
PlannedControlled reverse logistics and field-action scope is not yet an offer.
Clinical
Structure evidence needed by downstream regulated work.
Clinical evidence model
In developmentStudies, arms, populations, endpoints and conclusions form a thin foundation—not a full CTMS or TMF.
Biopharmaceutics
In developmentAnalytes, PK results and bioequivalence comparisons remain active model work.
Content & Medical
Assemble controlled outputs and govern external-facing content.
Regulated output composition
Early-access scopeInformation definitions, templates, mappings, snapshots and generated-output foundation.
Labeling, artwork, claims and MLR
PlannedVersioned external-content workflows remain roadmap scope.
Medical information and HCP/HCO governance
PlannedInquiry, response, engagement, grant and ethics workflows remain planned.
Focused entry points
Begin with the bounded workflow that can prove value first.
Next useful step
Bring one real workflow, not a transformation slogan.
We will map your current records, decisions, handoffs and deployment constraints to what exists—and identify the missing pieces plainly.