Supplier files: One living file per supplier, and a decision a person signs.
Six dated elements. Every gap has an owner.
One supplier's page: its decision and condition, what needs attention, and the facts on file. Brennick Compounding is a sample pharmacy; its suppliers, people, lots and figures are invented.
Qualified once is not qualified forever. Every file has a next review date.
A folder holds what a supplier sent once. It cannot tell you that the quality agreement lapses next month.
A folder forgets. A supplier file keeps the dates.
Veritura keeps one file per supplier that knows its own dates, names who owes each gap, and keeps watching after the file is signed.
Six elements. Each with its source and its clock.
Each element says where its evidence came from: matched at an FDA source, on file as the supplier sent it, or a gap.
Who made the substance. A certificate naming only a seller holds its lot.
The certificate, its own dates, and its scope matched to the tests on each certificate. Renewal due 30 days out, expired after.
Confirmed only when it matches a current FDA record. Searched at read and when the supplier is named.
The signed agreement and the renewal date it states. Due before the date, expired after.
Certificates against the panels you expect. A missing panel is named.
The supplier, the maker and the laboratory re-matched against openFDA enforcement hourly, and a review cadence and the last review, giving the file one status: current, due or overdue.
Owned, asked, signed, watched. One supplier, start to finish.
One supplier's file, Brookmere API Supply, as the workspace keeps it.
Every gap has an owner and a due date.
An open gap is assigned to a named person with a due date, and past it reads Overdue, on the file and in the queue. Reassigning keeps the earlier owner in the history. Only the document behind a gap closes it.
- A named owner, a due date
- Overdue the day after
- Closed by the document, never by a click
Requests drafted from what is open.
Each open gap becomes a named item on the supplier's checklist, such as the endotoxin result and its limit. The supplier answers through its door, a standing link with no account and no cost, and each document files itself to what it satisfies.
- Each gap, a named ask
- Answered through the supplier's door
- Filed to what it satisfies
A decision a named person signs.
Qualification ends in one of three outcomes: qualified, qualified with conditions, or not qualified. Qualified is refused while the file shows an open gap, and every decision carries a next review date.
- Three outcomes, nothing in between
- Conditions in writing
- Signed, and dated for its next review
Watched after it is signed.
Suppliers and lots on file are re-matched against openFDA enforcement records on an hourly cycle in production, and a match holds the lot. ClearGate reads the file at order time, so a change reaches the order before it ships.
- Hourly re-match against enforcement records
- A next review date on every file
- Read by ClearGate at order time
Not a binder. Four parts of the product read it daily.
Each reads the file's one status, current, due or overdue, and the elements behind it.
An expired accreditation, an enforcement match or an overdue review holds the order.
One of the nine receiving gates asks that the supplier packet be linked to the lot.
A certificate naming only a seller holds its lot until the original maker is named.
Cato walks supplier records in a surveyor's order, and the inspector's packet lists the files.
A qualification decision is a named person's judgment about the paperwork on file. It is never Veritura's approval of the supplier.
Claimed is not verified. Every item shows how it was checked.
The verified file adds 37 items of outside record, from licenses to warning letters, for a pharmacy vetting its suppliers or a clinic vetting the pharmacies it buys from.
State licenses, pharmacist in charge, NPI, DEA and FDA registration, and business standing.
PCAB, ACHC, NABP, LegitScript, the laboratory's ISO/IEC 17025 scope and GMP for makers abroad.
Inspections and 483s, warning letters, recalls, import alerts and HHS OIG exclusion.
Certificates checked, sterility, endotoxin against the dose's limit, potency and beyond-use dates.
503A eligibility, essentially-a-copy determinations, and the 503B testing and reporting duties.
The issuer's public source, the issuer in writing, a named person's check, the issuer's own document, or computed against the law.
Completeness grades the file, never the supplier. A typed claim shows as Claimed.
Every rule, in full.
For the reader who wants every rule before a call.
Supplier packet diligence, the standardThe six elements Source and clock
- Every value is real or absent
- A missing field is a gap, shown as a gap, never filled in and never left as an empty row. Dated documents run on their own clock: current, renewal due in the 30 days before expiry, expired after it.
- Manufacturer identity
- Who made the substance: legal name, address, FDA registration and FEI number. Matched at FDA's records where a current record exists; otherwise on file as supplied, or a gap. Clock: none of its own; a certificate naming only a seller holds its lot.
- Accreditation
- The accrediting body and the certificate itself, with the effective and expiry dates the certificate states, and its scope matched to the tests each certificate of analysis reports; a test outside the scope is named. Clock: renewal due 30 days out; expired after, which holds under ClearGate.
- FDA registration
- Labelled confirmed against FDA records only when it matches a current record. A number that does not match reads as supplier-provided, never as confirmed. Any enforcement or recall signal on the firm is shown here. Clock: registration searched at read and when the supplier is named; enforcement records re-matched hourly.
- Quality agreement
- The signed agreement and the renewal date it states, tracked like every other dated document you rely on. Clock: renewal due before the date, expired after.
- Documentation specifications
- The certificates on file against the panels you expect. A certificate that reads but is missing a panel counts as partial, and the missing panel is named. Clock: moves with each document received.
- Ongoing monitoring
- The supplier, the maker and the laboratory re-matched against openFDA enforcement records at check time and hourly, and a review cadence and the date of the last review, which together give the whole file one status: current, due or overdue. Clock: due 14 days out, overdue after, which holds under ClearGate.
The labels an element can carry
- Gap, on file, matched
- An element is a gap until something satisfies it. A document the supplier sent is on file: tracked, not certified. An element matched at an FDA source says so.
- Dated documents
- A dated document reads as on file while current, expiring in its renewal window, in the 30 days before expiry, and expired after its date. A certificate missing an expected panel is partial.
- FDA registration
- Shown as confirmed against FDA records only when the number or name matched a current FDA record. A number that did not match reads as supplier-provided, and when the verification data was unavailable it reads as not confirmed. It never says FDA-approved.
What holds, and what only asks for review
- High severity
- An expired accreditation, an FDA enforcement or recall signal on the supplier and an overdue review.
- Lower severity
- An accreditation or agreement coming due, a missing document and a partial certificate.
- Under your policy
- ClearGate turns these into Allow, Review or Hold under the policy you choose, and every reason names the rule that fired.
Owners, dates and decisions, as the product enforces them
- An assignment
- A gap's owner and due date are an assignment made by a signed-in person and kept with who assigned it and when. A due date in the past is refused. If two people assign the same gap at once, the second is told the page changed and nothing is overwritten.
- Never evidence
- Reassigning keeps the earlier assignment in the history. Nothing is deleted. An assignment is never evidence: a gap closes only when the document behind it arrives and the file reads it, so no gap is closed by a click.
- Three outcomes
- Qualified is refused while the file shows an open gap. The honest outcome then is qualified with conditions, and the conditions must be written down. Not qualified needs its basis stated.
- On screen
- “The file still shows 2 open gaps, so ‘qualified’ is not available. Record ‘qualified with conditions’ and state the conditions, or close the gaps first.”
- Signed and dated
- Every decision needs a next review date in the future, and past it the decision reads as due for review. A decision stands only once a named person signs it; until then the supplier has no decision on record. A later decision supersedes an earlier one, and none is erased.
- The review cadence
- Every file gets a next review date, a year unless you set another, and the whole file reads current, due or overdue against it.
The verified file, item by item 37 items
- Who it is for
- For a pharmacy vetting its suppliers, or a clinic vetting the pharmacies it buys from, the verified file adds the outside record in five groups, 37 items, each saying how it was verified and when.
- Who they are
- State license in the home state; pharmacist in charge; licensed in every state it ships to; NPI; DEA registration; FDA registration; FDA wholesale distributor reporting; business entity in good standing.
- Accreditation
- PCAB accreditation; ACHC pharmacy accreditation; NABP compounding pharmacy accreditation; NABP digital pharmacy; LegitScript for the website it sells through; testing laboratory ISO/IEC 17025 with a scope that covers each test; GMP certificate or CEP for makers outside the US; quality agreement.
- FDA and enforcement history
- FDA inspections, classifications, citations and 483s; FDA compounding actions; FDA warning letters; recalls; FDA import alerts; not excluded by HHS OIG; last state board inspection; adverse event signals, shown as context and not counted in completeness.
- Quality evidence
- Certificates of analysis, read and checked; sterility testing (USP <71>); endotoxin testing (USP <85>) against the limit computed from the dose; potency assay; beyond-use dates inside USP <795> and <797> limits; stability data behind extended dates; cold chain validation and temperature logs; sterile process validation; hazardous drug handling (USP <800>).
- Records the law asks for
- Substances eligible under 503A; essentially-a-copy determinations documented; every batch tested before release for an outsourcing facility (21 CFR 211.165 and 211.167); 503B duties: product reports, label statements and adverse event reports.
- Routes to verified
- Every item names one: matched at the issuer's public source, confirmed by the issuer in writing, checked at the source by a named person, read from the issuer's own document, or computed against the law or a standard.
How completeness works
- Completeness grades the file, never the supplier
- It is the share of the items that apply which are verified by one of the five routes and still fresh; a stale item counts half. A typed claim is shown as Claimed and counts nothing.
- A finding is verified information
- A recall, a warning letter, a 483 or an exclusion makes the file more complete, and is listed first, apart. Not found, name differs and expired are results too, never gaps hidden as passes.
- Automated only where the source allows it
- FDA, openFDA, NPPES and the OIG list are looked up by machine. LegitScript, NABP and most state boards forbid that, so a named person checks them, with a capture and a date. ACHC accreditation is checked by a named person against ACHC's own directory, with a capture and a date, and a name can also be matched against ACHC's public PCAB directory, which Veritura reads once a day.
- Published whole, findings first
- A pharmacy or supplier can publish its verified file. A finding the firm answers stays on the file, marked retired with its date, and no payment changes what a file says.
Where the file is read 4 places
- At order time
- ClearGate reads the file as one of four rails. Under your policy, an expired accreditation, an enforcement match or an overdue review holds the order, and a file still coming due sends it to review.
- At receiving
- A delivery goes through nine gates before it releases to inventory, and one of them asks that the supplier packet be linked to the lot.
- On every certificate
- A certificate that names only a seller holds its lot until the original manufacturer is named, from a maker line on the document or in a person's own signed words.
- At inspection
- Cato walks lot and supplier records in a surveyor's order, and the inspector's packet lists the supplier files and the originals kept.
What the supplier sees
- A door, free
- A standing link with no account, no login and no cost. It shows exactly what is owed, grouped by lot, and ticks items off as documents arrive. A supplier can keep every pharmacy's door in one free supplier account.
- Facts, never a grade
- The reply page states what arrived, what it states, and what is still asked for. A document that trips a document-integrity check is acknowledged and held for your review, and the supplier is never told which check it tripped.
What the file never claims
- Not an approval
- A qualification decision is a named person's judgment about the supplier paperwork on file at that time. It is not an approval, certification or rating of the supplier by Veritura, and it does not change what is checked when a lot arrives.
- Not a score
- Completeness is never a score of a firm. No match in a public source is a fact about the sources that answered, never proof of absence.
The boundary. A qualification decision is a named person's judgment about the paperwork on file at that time. It is never Veritura's approval, certification or rating of the supplier.
Questions, answered plainly.
Not as Qualified. While the file shows an open gap, Qualified is refused. Record qualified with conditions and write the conditions down, or close the gaps first.
No. A qualification decision is a named person's judgment about the paperwork on file at that time. It is not an approval, certification or rating of the supplier by Veritura, and it does not change what is checked when a lot arrives.
The file, never the firm. It is the share of the items that apply which are verified and still fresh. A recall or a warning letter found on the record makes the file more complete, and is listed first.
FDA, openFDA, NPPES and the OIG exclusion list, where the sources allow it. LegitScript, NABP and most state boards are checked by a named person, with a capture and a date, because their terms forbid automated queries. ACHC accreditation is checked by a named person against ACHC's own directory, and a name can also be matched against ACHC's public PCAB directory, which Veritura reads once a day.
No. A supplier answers through its door with no account and no cost, and a supplier account that keeps every pharmacy's door is free.
The decision reads as due for review, not as current, and the file's monitoring element reads overdue. Under your ClearGate policy, an overdue file holds the next order from that supplier until it is reviewed.
Still have questions? Talk to a person.