LabelMonitor automatically tracks every FDA DailyMed label update across your product portfolio — scoring severity against 21 CFR filing requirements and producing inspection-ready audit trails your team can defend.
Decision-support only. Not a regulatory determination.
FDA inspectors ask three questions your team needs to answer with evidence, not memory: what changed, when you knew, and what you did about it.
DailyMed publishes hundreds of label revisions weekly. Without automated monitoring, a critical Boxed Warning update to your reference product can go undetected for weeks — or until an inspector finds it first.
Telling an FDA inspector "we check DailyMed regularly" isn't evidence. Without timestamped, attributable records of who reviewed what and when, your monitoring process doesn't exist under Part 11 scrutiny.
When an experienced RA specialist leaves, they take years of product knowledge with them. Manual monitoring processes exist in people's heads — not in auditable systems that survive turnover.
LabelMonitor operates on FDA-authoritative SPL XML — the same structured data the agency publishes — so every detection is traceable to a primary source.
Register your ANDA products by NDC, ANDA number, or active ingredient. LabelMonitor resolves reference product linkages against Orange Book data and flags any discrepancies.
LabelMonitor polls DailyMed SPL XML automatically — detecting changes at the section level, not just version-level metadata. Nothing slips through.
Every detected change is automatically scored: section affected, filing classification (CBE-0, CBE-30, PAS, Annual Report), confidence, and the specific 21 CFR rule that applies.
Your team reviews, documents their assessment, and closes each notification. Every action is timestamped, attributed, and written to an immutable, chain-hashed audit trail.
Every design decision optimises for regulatory defensibility. Boring and auditable beats innovative and risky.
LabelMonitor operates on normalised SPL XML — detecting changes at the level of individual label sections (Boxed Warning, Contraindications, Dosage and Administration, and 20+ others) rather than blunt version comparison. Cosmetic reformatting is filtered from substantive content changes.
SPL XML · DailyMedEvery change is scored against a transparent, auditable ruleset. Assessments include rule ID, rule version, confidence score, affected section, and CFR reference. No opaque algorithms — every decision can be explained to an inspector line by line.
21 CFR 314.70 · CBE-0 · CBE-30 · PASEvery state-changing operation — ingestion, detection, assessment, adjudication — writes to a chain-hashed, append-only audit log. Records cannot be modified or deleted. The integrity of every entry can be verified cryptographically at inspection time.
21 CFR Part 11 · Chain-hash · Write-onceGenerate a complete evidence package for any product, any time period, on demand. Timestamped change history, adjudication records, SLA compliance, and reviewer attribution — exactly what an FDA inspector or internal quality audit expects to see.
PDF export · Audit evidence · SLA trackingLabelMonitor is built for environments where data confidentiality isn't optional — your product portfolio is competitively sensitive, and we treat it that way.
All data is encrypted at the storage layer. Portfolio contents, label versions, and adjudication records are never stored in plaintext. Encryption keys are managed separately from data.
AES-256-GCM · TLS 1.3 in transitEvery database query is scoped to your tenant ID. There is no administrative bypass. Your data is physically incapable of appearing in another organisation's queries — enforced at the service layer, not just the UI.
Row-level tenancy · No cross-tenant readsViewer, Reviewer, Adjudicator, Manager, and Admin roles enforce least-privilege at the service layer — not just UI visibility. Permissions are validated on every API call, not assumed from session state.
RBAC · Least-privilege · Per-call validationInfrastructure, access, and change controls are designed against SOC 2 Trust Service Criteria from day one. Audit evidence is available on request for your vendor qualification process.
SOC 2 · Vendor qualification supportLabelMonitor is designed around how pharmaceutical regulatory affairs teams actually operate — not as a single-user tool, but as a shared system of record with clear ownership at every step.
Receives alerts, reviews diffs, documents assessments, escalates high-severity findings. Has full adjudication rights on assigned products.
Dashboard view of all pending and overdue items across the portfolio. Generates inspection-ready SLA reports and manages team assignments.
Read-only access to audit logs, adjudication completeness, and chain-hash verification. Can produce internal audit evidence without touching live data.
LabelMonitor detects a section-level change in DailyMed SPL XML. The ingestion is timestamped, hashed, and written to an immutable record.
AutomaticRules engine classifies the change: section affected, severity level, and 21 CFR filing classification (CBE-0, CBE-30, PAS, or Annual Report).
AutomaticAssigned RA specialist receives an alert with the diff, severity rationale, and a direct link to the adjudication screen. HIGH alerts delivered within 15 minutes.
AutomaticReviewer documents their impact assessment, agrees or overrides the severity, and records the rationale. The entry is attributed, timestamped, and immutable.
Team actionThe complete chain — detection, scoring, notification, adjudication — is available in a signed, exportable dossier at any time. Nothing reconstructed after the fact.
Locked recordDesigned from day one for FDA-inspected pharmaceutical operations.
LabelMonitor is currently in controlled early access. We are onboarding a select group of regulatory affairs teams to validate the platform against real portfolios before general availability.
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