The law requires a valid certificate of analysis and names no way to check one. Veritura reads every certificate against the laboratory that issued it, the standard, the file itself and every other document seen, drafts the requests for what is missing, and the pharmacist signs the disposition with the reason kept. The record is ready for the inspector and for the patient holding the vial.
The job, in four moves
Certificate and shipment photo, read together. Identity and strength reconciled to the label.
The issuing lab, the standard, the file itself, every other document seen. Each ends in a state, never in silence.
A corrected-certificate request to the supplier and a confirmation request to the lab, drafted for you.
Clear, needs input, or hold, against your written policy, with the reason kept for the inspector.
The examination still happens and the pharmacist still signs it. Veritura reads, checks, drafts and keeps the record. We read documents. We do not test material.
01
Photograph the certificate and the shipment. Veritura reads the certificate, reconciles identity and strength against what the label says, and screens the source against FDA enforcement records, in the time it takes a tech to open the PDF today. Whether your record is a binder or a system, the fields are read for you, cited to the page, and the examination stops depending on who is standing at the bench.
The examination the regulation requires still happens, and it is faster and the same every time, because the reading is mechanical and the decision is against a written policy.
02
The lot clears, needs input, or holds against the written policy you set, on the record, and the pharmacist signs it. The policy is written once and applied the same way to every shipment, so the pharmacist’s judgment is exercised on the exceptions the record names rather than re-made from scratch on every lot, with the reason kept.
The signed decision on the record, with its reason, is what an inspector reads first, and the examination it documents is still the pharmacist’s.
03
The file a board inspector asks for goes stale the moment someone stops maintaining it. Each source's identity, FDA registration, accreditation, and history are kept current and re-checked, with a living current, due, or overdue status on every dated document, so a lapsed certificate surfaces before an order goes out against it.
The living file means the inspector's question is answered from the screen, with dates and origin labels, instead of from a binder somebody stopped maintaining.
04
When a buyer or an inspector asks you to prove a lot, you go digging. Veritura gives you one verifiable link backed by the lot's real documentation, and a serialized seal on the vial that lets a patient claim it, so if a lot goes bad the recall can reach the person who received it rather than stopping at the pharmacy.
One link proves a lot to a buyer or an inspector, and the serialized seal on the vial means a recall can reach the person who received it instead of stopping at your counter.
Why this exists
Federal law requires that bulk substances used in compounding be accompanied by a valid certificate of analysis, and names no method for establishing that a certificate is valid. Every pharmacy, facility, clinic, and platform in the chain is left to decide for itself. That gap is the whole reason an independent evidence layer exists.
The requirement appears in the federal compounding provisions for both 503A pharmacies and 503B outsourcing facilities. Validity is required. A way to establish it is not described.
In 2026 the FDA published a warning letter to a bulk supplier on its own published lists, describing relabelled active ingredient and altered manufacturing and retest dates. A buyer who checked the list and received a certificate still held a document that did not say what it appeared to say.
A large telehealth provider ran a per-batch certificate lookup from a code in each shipment for over a year and reported thousands of subscribers opening it every month. The demand for the record is not the question. Who checks it is.
What changes
Certificate and shipment photo read, identity and strength reconciled, source screened.
A board-ready binder built from live records, and a living file on every source.
Every cleared lot rechecked against live FDA recall and enforcement records.
The same steps every time, and the binder is never where the inspector is standing.
Each substance re-verified against the current FDA lists, so eligibility does not rest on the file you built last year.
A board-ready binder built from your live records, ready to export the moment you need it.
Every cleared lot and every supplier rechecked against live FDA recall and enforcement records for as long as you hold it.
Serialized vial labels let a patient claim their vial, so a recall can reach the person, PHI-free.
The complete text, for the reader who wants the whole story before a call.
A tech opens the COA, checks identity and strength, screens the source, writes it into a binder, and does it again on the next shipment. It is slow, it is the same steps every time, and the binder is only ever as current as the last person who maintained it.
Then a lot you cleared months ago gets caught in an FDA recall, and you hear it from a customer instead of from your own records. The examination was real work. The watching afterward was nobody's job.
Veritura turns the receiving examination into a scan, keeps the qualification file current on its own, and watches every lot you clear for the rest of its life.
A tech opens the COA and checks identity and strength.
The same tech screens the source against public enforcement records.
The result is written into the binder.
The next shipment starts the same sequence again.
The binder is only ever as current as the last person who maintained it. The examination was real work. The watching afterward was nobody's job.
Supplier, product and lot number are entered. All three are required; without them there is no lot to attach the record to.
The container label is photographed. The engine reads it and containment-matches the paperwork's product, strength and lot against the text.
The server fills in what it already holds: whether a supplier qualification file exists, whether a certificate for this lot was already read, and which panels are even in scope for this preparation.
Seven gates evaluate, one of four dispositions is written with the lot state it produces, and a draft correction request is composed from the specific gaps found.
The lot stays mapped against FDA enforcement records pulled on a cycle, so a record published months later still reaches it.
A person still decides. A label-to-paperwork mismatch stays the operator's explicit call, a photo that could not confirm a field records as unconfirmed rather than as a mismatch, and a hand-set Present with no evidence attached records as claimed-unverified.
How it works for you
Photograph the COA and the shipment. Veritura reads it, reconciles identity and strength, and screens the source against FDA enforcement.
The lot clears, needs input, or holds, against the written policy you set. Signed, on the record.
Every cleared lot is rechecked against live FDA recalls for as long as you hold it. You hear it first.
Nine stops in the order the product performs them. Each one names who acts, what the system does with what it already holds, and the state it leaves on the record.
A shipment lands on the bench.
Supplier, product and lot number are entered. All three are required; without them there is no lot to attach the record to.
400 identity_required when any of the three is missing.
The container is in hand.
The operator photographs the label. The engine reads it and containment-matches the paperwork's product, strength and lot against the text. The photo-read tier is earned server side under a one-time token bound to the account and to that lot, never echoed by the browser.
The token expires in an hour and is kind-scoped, so a temperature-report token can never dress the label gate.
The form is submitted.
What the server already knows is filled in before deciding: whether a supplier qualification file exists, whether a certificate for this lot was already read, and which panels are even in scope for this preparation. Only blanks are filled; an explicit operator entry always wins.
Out of scope is not a gap. A non-sterile topical was being quarantined for sterility and endotoxin it never needed.
The seven gates evaluate and one of four dispositions is written with the lot state it produces. A draft correction request to the supplier is composed from the specific gaps found.
The record is saved.
The lot is upserted from the receipt. A clean receiving release does NOT lift an existing flag when a recall still stands, when the flag was routed for human review, or when a high-severity documentation finding stands: a receipt cannot answer a document finding, a corrected certificate can.
A re-receipt that comes back quarantine or correction supersedes an earlier auto-clear until the gates pass again.
New evidence landed on the lot.
When the account's policy has auto-decide on, ClearGate re-runs against the lot immediately and stores the signed decision, through the same path a manual run uses.
An order ships, from the workspace or from the API.
The order is written with its lot number. The lot is resolved by number within the account and stamped as an exact reference. An ambiguous lot number matching several lots is refused, never guessed.
The floor is checked: the lot must exist, be cleared, carry no ClearGate hold and no recall signal, and satisfy any human-review or ClearGate-Allow requirement the policy sets.
A live recall blocks the mint on its own, independent of state, so the gate never rests solely on clearGateHold.
A lot is ready to go out the door.
Serials are minted against that lot in the shape VS-XXXX-XXXX, collision-checked against every serial already issued and against the batch's own output. When order references are supplied, each serial is bound one-to-one to one order at mint time.
The binding is the right-patient guarantee, and it is PHI-free: order references only, no patient identity exists to mis-route.
The label goes on the vial. Where serials were bound to orders, packing becomes the same label-to-packing-slip match the pharmacy already performs for addresses.
Documentation receiving gate only. This is not a product quality, safety, efficacy, compliance, or FDA-approval determination.
Today the receiving examination is a person opening a PDF and transcribing fields by hand. Veritura reads the COA and the shipment photo, reconciles identity and strength, screens the source, and files it.
A 60-second scan instead of a binder chore, and the record is kept for you.
Whether a lot may be used is a judgment call made and re-made by whoever is at the bench. Veritura runs each lot against the written policy you set and returns Allow, Review, or Hold, with the reason on the record.
Your release policy, applied the same way every time and signed.
The file a board inspector asks for goes stale the moment someone stops maintaining it. Veritura keeps each source's identity, FDA registration, accreditation, and history current and re-checked on a cadence.
Always ready to hand over, with nobody re-typing it.
Whether a substance is still eligible to compound shifts as the FDA lists change, and nobody re-checks the file you built last year. Veritura re-verifies each substance against the current lists every day.
You are told when a substance's status moves, not months later.
A recall on a lot you cleared last quarter is invisible until it reaches you the hard way. Veritura rechecks every cleared lot and every supplier against live FDA recall and enforcement records continuously.
You find out before it becomes your problem.
When a buyer or an inspector asks you to prove a lot, you go digging. Veritura gives you one verifiable link, backed by the lot's real documentation.
The proof on demand, that a gray-market seller cannot produce.
An inspection means assembling the whole file under pressure. Veritura keeps a Board-Ready binder built from your live records, ready to export the moment you need it.
Inspection day is a download, not a two-day scramble.
If a lot goes bad you cannot reach the patients who received it. Veritura's serialized vial labels let a patient claim their vial, so a recall can reach the person, PHI-free.
The recall reaches the patient, not just your shelf.
What you can skip: You do not need the brand-claim tools or the telehealth API. This is the receiving, sourcing, and inspection desk for your bench.
At the loading dock
Match the label to the paperwork, read the micro evidence, and set the lot state before anything moves downstream.
the fast path: one photo, no typing
Photograph the COA or packing slip that came in the box. The document engine reads the supplier, product, and lot, runs the same receiving gate as the form, and hands back the shelf answer, RELEASE or QUARANTINE, with a printable green or red shelf tag for the tote.
matched - photo read · matched - operator attested · not checked · blocker
A photo that could not confirm a field is 'unconfirmed', never a hard mismatch. Absence of proof on a photo is not proof of conflict, so the hard mismatch stays the operator's explicit call and a photo can only ever raise the tier.
The lot's own document set counts. If a certificate for this lot was already read, the gate resolves it rather than asking the operator to re-supply what they just supplied.
on file · claimed - not on file · not linked
A real lookup, not the operator's word. A ticked checkbox with no qualification file on record is surfaced as claimed-but-not-found.
present · present - unverified · not applicable · not tested · missing
When the COA text is attached, the result is read off it rather than taken from a typed status. A panel out of scope for the preparation is marked not applicable, never counted as a gap.
present · present - unverified · not applicable · not tested · missing
Same read-it-rather-than-ask-it rule as sterility.
documented - report read · excursion stated - report read · present · missing · not required
An uploaded data-logger report outranks the typed status and its own stated outcome is quoted verbatim. A stated excursion becomes a documentation gap for review rather than being absorbed by a typed 'present'.
clear · clear - unverified · review · not checked · hit
A hit is a hard blocker. 'Clear' with no screen terms attached is reported as clear-unverified, not clear.
Supplier, product and lot number are entered. All three are required; without them there is no lot to attach the record to.
What the server already knows is filled in before deciding: whether a supplier qualification file exists, whether a certificate for this lot was already read, and which panels are even in scope for this preparation. Only blanks are filled; an explicit operator entry always wins.
One of these four
No hard blocker, a COA present or referenced, no micro gap, and temperature evidence not missing.
A soft gap only: label match not checked, no supplier qualification file on record, or the source screen not attached.
No COA attached or referenced, a sterility or endotoxin gap, or temperature evidence expected and missing.
A hard blocker: the operator recorded a label-to-paperwork mismatch, or the FDA source screen returned an enforcement hit.
Documentation receiving gate only. This is not a product quality, safety, efficacy, compliance, or FDA-approval determination.
ClearGate reads the file and your configured policy and returns one decision when an order is placed. You set the bar; we keep the record.
ClearGate: AllowMeets your policy
ClearGate: ReviewNeeds review
ClearGate: HoldDoes not meet policy
A ClearGate decision always means the documentation meets your policy. It never means Veritura approves the supplier.
An order is screened, a check is saved, or a shipment is received.
ClearGate evaluates. When the policy has auto-decide on, no one has to click Run; the trigger is recorded but the record produced is identical to a manual run.
The supplier qualification file and the lot are read against the policy. Hold beats review beats allow. Every reason carries the policy rule code that produced it.
The decision is signed and hash-chained to the one before it, with the policy version pinned inside the record.
The decision is stored.
A hold stamps clearGateHold on the lot, which blocks the passport on its own. A later allow or review clears that hold; the signed record itself is never mutated.
ClearGate reports documentation conformance against the policy the customer wrote. The customer owns the policy; Veritura owns the verification. A decision is never a product pass, a safety statement, or an approval.
The evaluator returns codes, not adjectives. Hold beats review beats allow, and a decision replays from the stored evidence and the pinned policy snapshot to the identical label and reasons. Every Hold and Review code, and what each one means, is listed against the decision that emits it on the ClearGate page.
Strict, Standard, and Lenient presets on the Clinic plan. Per-rule toggles, thresholds, and operator-attested items on Facility, with a tamper-evident signed decision log either way.
Every element is labeled Veritura evaluated, read from the document or a public source, or Operator attested, where you confirm what we cannot read. The file never overstates what was checked.
The stored evidence and the pinned policy snapshot are fed back through the same evaluator. A correct decision replays to the identical decision, label and reasons; anything else means the record was altered.
All three re-run automatically when new evidence arrives. Only Strict withholds the release: Standard and Lenient release a passport the moment the policy allows it, Strict keeps that click with a person.
What an inspector sees
Know today how much of a records request you could hand over. Coverage counts against named references, never a compliance determination.
One click pulls your lots, suppliers, issued passports, and any FDA enforcement or recall exposure into one inspector-ready PDF, organized for a board or FDA records request. Documentation diligence only, not a determination of compliance.
Every substance you compound as one living record, so an FDA list change never reaches you weeks late through a newsletter.
A qualification file is the file you keep on each supplier, and a state-board inspector grades it as a living system, not a one-time onboarding folder. Veritura builds the file as six structured elements, keeps each dated document current, and gates every order against it.
Legal name, address, FDA registration and FEI number, confirmed against the openFDA registration snapshot when one is available, marked on file when it is not.
NABP, VAWD, or equivalent held with its effective and expiry dates, so a lapsed certificate surfaces on the file before an order goes out against it.
Registration and listing checked against live openFDA enforcement and recall feeds, with any hit on the firm surfaced directly on the file.
The signed quality agreement and its renewal date are held on the file and tracked the same way as every other dated document you rely on.
Your required COA panels and document standards for the supplier, evaluated against what each packet actually contains, not assumed.
A review cadence with a next-review date, so the file carries a living current, due, or overdue status instead of a stamp.
What you hand over
They are two products that happen to describe the same lot. The Passport is a record you send. The Seal is a sticker you apply.
When a buyer or an inspector asks you to prove a lot, you go digging. Veritura gives you one verifiable link, backed by the lot's real documentation. The cleared lot is the gate, so an uncleared lot can never publish a passport.
Sandbox records are free for testing.
A serialized QR code printed onto the vial label itself, one per unit, from a label sheet or straight to a label printer. The patient scans the vial in their hand. Nothing to email and nothing loose in the box.
Shipping to ordersShip orders mints one seal per order with the order number printed on the sticker, plus the passport itself. Match sticker to packing slip, and the patient's scan shows their own order.
Sealing stockFrom any lot record: up to 500 lot-level labels at a time, printed as Avery 5160 sheets, a thermal roll, or raw ZPL straight to your label printer. The API mints them from your own system too.
The recall reaches the patient, not just your shelf.
A passport is minted from a lot, never from a claim, and every element on it says who established it.
The document set for this lot's subject and dosage form is complete, it carries no unresolved high-severity finding, and the lot has a named supplier and lot number. That cleared lot is the gate: a release attempt on an uncleared lot comes back with the name of the unmet requirement instead of a published record.
An outside record answered. Either a registration matched a current FDA record, or the issuing laboratory's own recorded reply resolved the document. Only the laboratory's reply ever sets confirmed.
The passport is bound to the lot it was minted from, and the binding is permanent. That is what lets an FDA enforcement record published months later reach a passport that is already in a buyer's hands.
Every row carries the origin that established it. Operator attested means a person stated it and the record stamps who and when; reading the document behind an attestation still never verifies the practice behind it.
Sharing publishes the record at a public verify reference. That page prints the read, the laboratory and the date, and states documentation completeness in plain words with no number. A number beside the name of someone's medicine reads as a quality grade, which it is not.
Shown to the patient or buyer: Documentation reads complete
An Evidence Passport publishes what the documentation for a lot states and where it came from. It is not a certificate of quality, an approval, or a statement about the medicine.
The document set met the configured policy. It describes the paperwork, not the medicine.
The issuing laboratory confirmed issuance through the recorded verification route.
OrderPO-DEMO-0413
LotLOT-7741-A
SupplierAurora Pharma Supply
Quantity250 g
ReceivedJuly 22, 2026
ReleasedJuly 23, 2026
Passport issuedJuly 23, 2026
Methodologyv1.0 · April 30, 2026
COA-7741-A.pdf · Issuing laboratory confirmed issuance through the recorded route
CoC-7741.pdf · Required identity, lot, and date fields present
SDS-SEMA-04.pdf · Current revision on file
GMP-AUR-2026.pdf · Supplied by the operator
Recorded in workspace · Container and label checked at receipt
LBL-7741-A.jpg · Lot identifier matches the certificate of analysis
Recent FDA drug enforcement records are pulled inside a rolling window and scanned for lot numbers the system already knows. Only distinctive lot numbers are eligible: a short all-digit number needs six or more digits and must not be date-shaped, because those appear constantly in enforcement texts as catalog numbers and dates, and a false recall flag on a real customer lot is far worse than a missed fuzzy match.
Enforcement records in hand.
Each record's code info and product description are scanned for known lot numbers. A match must sit on a token boundary, so '1305' can never match inside '213055'. A product hint keeps two unrelated suppliers reusing the same lot number from being conflated.
Every matching lot, in every account that logged it, flips to flagged and carries the recall signal with its hits, confidence, detail and the lot number that matched.
A flagged lot has passports minted from it.
Every passport bound to that lot is stamped with a post-release recall signal. Stamping is idempotent: the record stays in the FDA window for its whole duration, so a repeat sweep refreshes the existing signal in place rather than stacking duplicates.
The passport stays bound to its lot forever, which is what lets a later recall reach it at all.
The operator decides to tell the people holding the product.
One button reaches every active claimant on that lot's seals. The pharmacy makes the call; the software does not send to patients on its own.
What a recall signal blocks: A lot carrying a recall signal mints no new passport and releases none, independent of every other state on the record.
A lot-number match against public FDA enforcement data is a documentation and enforcement signal, never a safety or approval determination. A lot number can be reused across firms, so the firm identity and the lot must be confirmed against the FDA record.
Free
Clinic
Facility
What each one carries.Nothing here is bundled into a lower tier than the one it is listed under.
A COA check or Passport records whether the documents are complete and consistent. It is not a safety, quality, efficacy, legality, or FDA-approval claim.
Veritura does not test medicine, approve suppliers, recommend purchases, or make medical, legal, product-safety, or FDA-approval determinations. There is no paid or subjective placement: suppliers cannot pay for a better result or a better position, no listing fee, no subscription, and no pay-to-rank. Where results are ordered rather than filtered, the order is set by a published documentation-coverage grade, and that grade is never a recommendation, a preference, or a statement about any product.
The receiving examination becomes a scan: the certificate and shipment photo are read, identity and strength reconciled, the source screened, and the lot cleared to your policy with the reason kept.
A board-ready binder built from your live records, with every supplier file, cleared lot, and decision current as of the pull, plus a living six-element file on each source.
It stays watched against live FDA recall and enforcement records for as long as you hold it, and a serialized seal on the vial lets a recall reach the person who received it.
Still have questions? Talk to a person.
Veritura · standardOrder-level COA traceabilityThe twelve fields every order should resolve, and the line between operator and customer views.
Veritura · guideThe release gateThe six gates every output clears before release.
Veritura · launch noteCustodyThe chain of custody compounded medicine never had: three hands, one record.