An auditor tells you what is wrong, then leaves. Find it first and you still have time.
You send your procedures, your qualification and validation packages, and a sample of your records. Your own people show us the building on a video walkthrough, which is part of every assessment. We check all of it against every requirement of one certification standard or FDA rule, for one site, at one fixed price. Then we tell you what is wrong. That means what is missing. It also means what is there but not good enough. It means where two of your documents disagree, and where a procedure says something your records do not back up.
The standards and FDA rules we check you against.
Each assessment covers one standard or FDA rule, at one site. Before we offer it, we work out every one of its requirements from the published text. Pick the one you are audited or inspected against. If you are getting ready for an FDA inspection, pick the FDA rule that applies to you. If you make finished supplements, two could apply. The request you were sent tells you which: NSF/ANSI 455-2 certification, or NSF GMP registration. If it names neither, ask whoever sent it which one they mean.
What you get, and what we will not claim.
The limits matter as much as the work. An assessment that promises more than it can see is no use the day the auditor walks in. So here is where ours stops.
What it does
- Checks every requirement of the standard you picked, in the standard’s own order. Each one is described in plain words with its clause number. The standard’s own text is not copied
- Reads every document you send. We read them, we don’t just search them for keywords. When a document answers a requirement, we name it and point to the spot
- Checks each document against the requirement it is meant to meet, and says where it falls short
- Names what is missing outright. It is marked not found, never quietly passed
- Names what is there but not good enough. A limit with nothing behind it. A procedure written for an operation you don’t run. A step that stops short of what the standard asks
- Names where one document contradicts another. Say your supplier procedure requires requalification every year, but your approved supplier list says every three. It also names what a procedure claims that its records do not prove
- Groups repeat findings under the one problem causing them, so you get causes, not a pile of symptoms
- Gives you the findings, a map of every requirement to what answers it, a map of how your documents point to each other, and a workbook of all of it, numbered the way the standard numbers it
- Puts the work in the order it has to be done, so you don’t fix a symptom and pay to fix it twice
What it will not claim
- We don’t predict your grade. The auditor rates each finding on the day. Then a reviewer at the certification body checks those ratings before the grade is set. Anyone promising you a grade is guessing
- We work only from what you give us. The assessment rests on the documents you send, what your people show us on the walkthrough, and what you tell us about your operation. We don’t check any of it against outside sources
- We don’t write your procedures or tell you how to run the place. For each finding, we name what would close it: the missing record, decision or document
- It is not legal advice. It is not a certification or registration decision, and it doesn’t grade your operation
We ask for exactly what we need, once.
After you buy, you get one guided request. It names each document and says in plain words what it is. It also gives the other names it goes by, so you can spot it in your own files.
Pick the standard
You tell us which standard or FDA rule to check you against. One standard, one site, one fixed price.
One guided request
Your procedures and controlled documents, your qualification and validation packages, and a sample of your records. The request names which records and which dates. Nothing is open-ended, and you don’t upload the whole file room.
We check it before the clock starts
We look at what arrived and confirm it is complete. If something important is missing, you hear about it then, not five days later. Then we book the video walkthrough.
Five business days
The five business days are counted from when we have everything. You get back the findings, a map of every requirement to what answers it, a map of how your documents point to each other, and the workbook.
There is no meeting and no discovery call. You buy it, send your files, show us the building on the video walkthrough and get the work back. The walkthrough is the one call, and it is part of every assessment.
Why not just ask a chatbot? You’d get an answer that reads well, with no way to tell which parts are wrong. A chatbot sounds just as sure when it’s wrong. And nobody stands behind what it says. We use AI in this work too. Here it is checked against every requirement of the standard, listed before the work starts. It is judged the way an auditor would judge it. Nothing reaches you until one of us has read the whole assessment and released it.
No site visit is part of an assessment. That is what the walkthrough is for.
Some requirements are about the building itself, or about what people actually do in it. Whether a sewage line vents inside the plant is not something a written procedure can answer. No document can answer those, however good it is. Every standard has some.
We name every one of them. Any the walkthrough does not show stay open, and open is not a pass. Knowing exactly which ones they are keeps you from preparing for the wrong audit.
The walkthrough is included in every assessment, and it answers some of them. Only what is shown on it gets answered and carries findings. What isn’t shown stays unanswered.
It is not an inspection, an audit or a site visit. No site visit is part of an assessment. If you want someone on site, that is consulting, quoted separately. Your own people hold the camera. We say what to show and ask the questions. Every finding from it says so, and says what was shown and on what date.
Facility Walkthrough, on Video
- A scheduled video call, on whatever platform you already use
- Your own people walk the operation, receiving through to shipping
- We say where to point the camera and ask the questions the standard depends on
- Three to four hours, on your schedule. We don’t record the call. What it shows goes into the findings, with who showed it and when
- What is shown comes back answered in the same report as everything else. What is not shown comes back marked unanswered
If you want it closed, that is a separate decision.
For each finding, the assessment names what would close it: the missing record, decision or document. Then it stops, on purpose. An assessment that also sells you the fix has a reason to find more.
What it does is make the fix easy to price. With every problem named and in order, the fix can be quoted properly. That quote comes through Consulting, as its own proposal with fixed terms you take or turn down. Buying the assessment commits you to nothing. It is complete and useful whether you ever ask for the fix or not.
An assessment tells you where you stand. Sometimes that is not what you need.
Sometimes one document is the whole problem. Sometimes you already know the standard and only need the system built. Here is where to go for each.
Not legal advice. An assessment is a read of the records you send. It is not legal advice, not a certification or registration decision, and not a prediction of your audit or grade. The certification body decides those. No site visit is part of an assessment. If you want someone on site, that is consulting, quoted separately. We don’t grade your operation or fix anything. Anything that turns on the building or on what people do gets a finding only from the video walkthrough, which is included in every assessment. Only what is shown on it gets answered. We rely on what you send and tell us, and we don’t check it against outside sources. What you send stays confidential and is never used to train a public AI model. We keep it only as long as we need to do the work and meet our record obligations. The companies, documents and findings in our examples are made up, but the rules are real. Regulatory Options is not affiliated with or endorsed by NSF, SQFI, BRCGS, FSSC, ISO, the USDA or the U.S. Food and Drug Administration.