COA & Testing Management
Track manufacturer COAs, third-party lab reports, verification testing, identity, heavy metals, micro, potency, and label claim verification against your written specifications.
Batch Documentation & Release
Connect finished product lots to formulas, manufacturer batch documentation, specifications, testing records, COAs, deviations, approvals, and release signatures.
PO & Receiving Workflows
Manage production POs, warehouse and 3PL receipts, receiving documentation, quantity checks, discrepancies, and inventory release decisions in one connected workflow.
Manufacturer Qualification
Maintain approved contract manufacturer lists, manufacturer status, quality agreements, requalification dates, audit history, COA reliability, open nonconformances, and risk scoring.
Document Control
Organize SOPs, specifications, labels, COAs, batch records, CAPA reports, complaints, adverse event files, certificates, sample submissions, and recall documents in one searchable repository.
CAPA & Deviations
Open, assign, investigate, track, and close deviations, OOS events, complaints, and corrective actions with linked records and due dates.
Audit Trails & E-Signatures
Capture permanent time-stamped audit trails and electronic signature events for controlled reviews, approvals, and release decisions.
Training Management
Assign SOP training, track employee completion, identify overdue training, and connect training records to controlled procedures.
Audits & Inspections
Plan internal audits, contract manufacturer audits, mock FDA inspections, warehouse audits, findings, follow-ups, and related CAPA actions.
Complaints & Adverse Events
Log product quality complaints, adverse event files, severity, affected lots, investigation status, related CAPAs, and required documentation.
Recall Readiness
Maintain recall files, mock recall exercises, affected lots, distribution traceability, and documented recall decisions.
Certifications
Track third-party sports testing programs, renewal dates, batch submissions, and certification status before product release.
Quality Metrics
Real-time quality KPIs such as release cycle time, OOS trends, manufacturer reliability, CAPA aging, complaint trends, and testing turnaround times.
Batch Genealogy
Trace contract manufacturers, production POs, COAs, finished product lots, complaints, certifications, and release decisions in one connected tree.
Manufacturer Portal
Allow contract manufacturers to submit COAs, CoCs, batch documentation, spec sheets, quality agreements, and requested documents directly into controlled review workflows.
AI Quality Assistant
Highlights manufacturer risk trends, batch release bottlenecks, expiring certifications, overdue actions, OOS patterns, and recommended next steps.