GRM User Guide

GRM (Global Regulatory Monitor) collects pharmaceutical GMP and quality regulatory news that is scattered across FDA, EMA, MHRA, PIC/S, ICH, WHO, Health Canada, MFDS and other authorities, and organises it into a card-based brief every week. This page is arranged around how you actually use the site, not around a feature list.

A note on languages: the weekly brief, the glossary and some curated copy are published in Korean, and the English edition covers the findings database, the library, this guide and the weekly quiz. Where a section below describes a Korean-only surface, it is marked as such.

Start here — the site at a glance

Working from the top menu, each screen is used like this.

• Home: the entrance to this week's brief. Alongside the service introduction you will find this week's collection and card status, the cards that drew reactions, and the entrance to the weekly quiz.
• Weekly brief: past briefs gathered by week. You can search previous issues and cards by keyword or authority. Published in Korean.
• Findings: a database for searching the individual findings inside regulatory documents. If the brief is "this week's newspaper", findings search is the "cumulative reference archive". It is split into a search surface and a browse surface (task shortcuts, recently published documents, exploration by axis).
• Trends: a statistics screen that aggregates all findings. You can see the last 12 months of movement and what changed against the preceding 12 months, category rankings, the year-by-year mix, the most cited clauses, company rankings, source composition, and the difference between foreign and domestic US inspections — and the clause ranking leads on to the self-assessment checklist.
• Library: reference documents you come back to — GMP guidance, notices and standards published by regulators and professional bodies at home and abroad — gathered into catalogues by organisation (refreshed automatically every week).
• Guide: this page. At the bottom there are also routes to the glossary and the weekly quiz (reachable any time from "Explore" in the footer).

Monday morning: reading the brief in three minutes

A new brief is published every Monday. On a busy Monday we suggest skimming it like this.

1. From the home page, press Read this week's news to open the brief.
2. Read the This week's key points summary at the top first. The few most important matters in the issue are set out one line each.
3. From the contents on the left, jump straight to the authority or type section that matters most to your company. If you export to the United States, for example, start with the FDA section.
4. In a week with many cards, switching on the summary view toggle turns the cards into a one-line summary list. Skim the titles and open only the cards that catch your eye.
5. For cards that touch your own work, read through to the implications and checkpoints, and if the team needs to see it, use the card's share button to copy that card's link and pass it on.

Done this way, you can grasp "what happened this week, and what we need to check" in three minutes without reading everything end to end.

How to read a brief card

The anatomy of a card

One card is one regulatory document or action. Read it from top to bottom like this.

1. Title and summary: what happened.
2. Badges: evidence level, issuing authority, signal strength, and the product group concerned.
3. Key facts: facts confirmed in the source document — issue date, document number, company, the action taken. Important English sentences appear with the original quotation and the Korean translation side by side.
4. Implications and checkpoints: questions to consider against your own work. This part is GRM's interpretation, so it is set apart by colour and should be read separately from the facts in the source.
5. Source links: from the foot of the card you can move to the public context and to the official original.

For matters that deserve a closer look — warning letters, administrative actions, FDA 483s — cards carry an additional deep analysis collapsible block. Open it to see the main violations and the required actions together with quotations from the original.

Information source and official original

Two kinds of link can appear at the foot of a card.

• Information source: the route by which GRM discovered and collected the information (an authority's listing or index, a public notice board, and so on).
• Official original: the actual document file or source page published by the regulator. When you need to confirm the exact wording, the scope of application or a deadline, go to this link first.

When the two links are the same page they are merged into a single information source / official original link.

Evidence and Signal badges

• Evidence A, B and C indicate what kind of supporting material the card is connected to. A means a citable primary source has been secured, B means there is an official basis but no citable original text, and C means only a secondary source has been secured. It does not express the importance of the matter or its legal risk.
• Signal T1 to T3 is a priority marker for deciding what to review first. T3 is the highest review priority. It is not a risk class set by a regulator, nor a judgement about the severity of a violation.

Do not conclude that a company or product carries legal risk merely because a badge is high; judge the real meaning from the document type and the wording of the original.

Searching findings, in practice

Findings search lets you search by keyword across individual findings extracted from FDA 483 observations, warning letters, Health Canada inspection reports, MFDS GMP inspections, and EU and UK GMP non-compliance reports.

Search terms to start with

• data integrity — findings about records and audit trails
• aseptic — findings about aseptic processing and environmental monitoring
• OOS — findings about out-of-specification investigations
• CAPA — findings about the corrective and preventive action system
• cleaning — findings about cleaning validation

Search matches on substrings, so aseptic also finds aseptic processing and aseptic area. Short key terms find more than long sentences; if a search returns little, try a synonym before a longer phrase. This edition shows findings whose original text is in English by default — the note above the results says so, and one click removes the filter to search the whole corpus, including findings whose original is in Korean.

Worked examples

1. Preparing for an inspection: search the keyword for the area you are preparing (for example data integrity), then combine the source, quality category and publication month filters to see the recent direction of findings. What others were cited for recently becomes your own self-assessment list.
2. Checking one company's history: use the company filter or search the company name to gather that company's findings history. Pressing the company name in the results takes you to the company profile screen, which organises its cumulative history by category and year.
3. Getting the wider picture: looking at the trends screen before any individual search shows you which categories of finding are increasing and which companies appear often.

Reading the results

Search results are shown grouped by document. One document can contain several findings, so the number of findings and the number of documents can differ. The same wording can also mean different things depending on the product, the process and the scope of the inspection — so do not draw conclusions from counts alone; open the document and confirm the context and the official original.

Using the library, glossary and quiz

• Library: unlike the brief, which flows past every week, this is a reference catalogue you come back to. GMP and quality documents published by regulators and professional bodies at home and abroad are divided into catalogues by organisation, and every item links straight to the official original. The library's front screen shows at a glance which catalogues exist and how many items each holds. It is useful when you want to find a document again later, after the brief covered it once.
• The library refreshes itself every week: each organisation's public page is checked early every Monday and newly posted documents are taken in automatically. What arrived that week can be seen in "Recent updates" on the library's front screen, above the weekly brief archive, and — down to the document titles — in the weekly newsletter. If too much changes at once, or documents disappear, automatic adoption stops and a person checks first; and if collection fails for one organisation's page, the remaining catalogues still refresh normally.
• Glossary: explains the terms that appear often in GMP and regulatory documents, with plain-language definitions and official sources. It is searchable in either Korean or English and can also be browsed through the Korean alphabetical index. Published in Korean.
• Weekly quiz: a short quiz, drawn afresh each week, that revises regulatory and quality terms and recent public cases. Everyone answers the same questions in the same week, and choosing an option shows the answer, the explanation and the source link straight away. No ranking or record is kept, so it works comfortably as team study or as an ice-breaker before a meeting.

Frequently asked questions

When does a new brief come out?

Every Monday. If you subscribe to the newsletter you also receive the key summary and shortcuts by email the same day.

Where do I find past briefs?

They stack up by week under Weekly brief in the top menu. You can also search past cards with the keyword and authority filters.

Can I rely on the summary alone?

No. AI is used in GRM's translation, summarisation and implications, and the result is a reference aid for finding documents and making a first pass. Anything that bears directly on a decision — the violation, who it applies to, deadlines, requirements — must be confirmed again in the official original linked at the foot of the card.

How do hearts and scraps work?

The heart (agree) and scrap (read later) buttons at the foot of a card are available after email sign-in. Scrapped cards can be seen again under My activity in the account menu once signed in, and the cards that drew reactions are featured in "Cards that drew reactions this week" on the home page.

The finding I want does not come up

Try a shorter key term, and try a synonym — regulators word the same problem differently. If it still does not appear, release the language filter to include findings whose original text is not in English, and check the collection source note at the top of the findings search screen: the document may not yet be within the collection scope.

Newsletter subscription

Enter your email in the subscription form at the foot of any page and we will send the key summary and shortcuts for that week's brief by email every Monday. A confirmation email is sent when you sign up, and the subscription completes only when you press the confirmation button in that email. You can unsubscribe with a single click from the foot of every email.

Before you rely on this

• AI may be used in GRM's translation, summarisation and implications. Technical terms, negations, conditions, figures, dates and scope of application may be conveyed differently from the original.
• Legal and regulatory judgements must be based on the official originals published by regulators and on current law and guidance.
• Check the document's issue date and whether it has since been revised, the products, sites and processes it applies to, and whether any follow-up response, correction, withdrawal or further action exists.
• Matters affecting licensing, quality, legal or regulatory response should be decided after review with the relevant specialist department. The summaries and interpretations in this service are not the views of any regulator, and are not legal, regulatory or quality advice.