How Claritas Axis works
Most practices don't fail inspections due to bad intent. They fail because nobody told them what was required. Claritas Axis gives you a clear picture of where your gaps are and a path to fix them.
The compliance journey
Step 1 — Take the free snapshot
10 questions. Under five minutes. Instant result categorized as Low Risk, Moderate Exposure, or High/Critical Exposure. No sales call. No commitment.
Step 2 — Get the full picture for $99
81 questions covering all 10 FDA-evaluated areas. Includes your Authorized Trading Partner registry and a personnel roles section. Practice-specific gap report delivered instantly and automatically.
Step 3 — Build your SOP for $999
A custom Standard Operating Procedure built directly from your assessment results. Not a template built specifically around your gaps, ranked by severity.
Step 4 — Expert implementation for $1,599
Everything in Step 3 plus a one-on-one owner call, administrator walkthrough, staff training session, and a live inspection support line. If FDA or a state inspector walks in call us. We guide you through it in real time.
Step 5 — Stay current for $199 every six months
Your SOP reviewed and updated every six months to reflect new FDA guidance, enforcement priorities, and state regulatory changes.
What inspectors evaluate
Vendor verification — Every Rx product must be traced to an FDA-registered authorized trading partner.
Purchasing controls — Purchase orders and invoices must be documented and retained for three years.
Product receipt — Every shipment received must be verified against transaction documentation.
Storage controls — Temperature, lot tracking, and expiration date management must be documented.
Inventory tracking — Every unit must be traceable by lot number from receipt to administration.
Administration documentation — Every product administered must be linked to a patient record.
Purchase to patient reconciliation — What you bought must reconcile to what you administered. No unexplained variances.
Recall handling — A written procedure for suspect and illegitimate product must exist and be communicated to staff.
Record retention — Transaction records must be retained and producible on demand for three years.
Governance and training — A designated compliance owner with defined authority must be identified.