Regulatory library for GxP teams: FDA, ICH, EU GMP, EMA and PIC/S guidance with page-level citations
The QLogix regulatory library is a searchable index of the regulations and guidance GxP quality work answers to, built from the official documents so that every answer cites the document, its code and the page. It holds FDA guidance and regulations, ICH guidelines, EU GMP, EMA guidelines and PIC/S documents, each with its status (Final, Draft or Superseded) and official link, and it is checked against each issuer every week. Licensed publications (ISPE guides, PDA technical reports, USP general chapters and ASTM standards) are listed with their official links and their text is not reproduced; an organization that holds a licence adds its own copy, which is searched for its users only. Q Intelligence, Q Agent, scheduled agents and connected systems read the same library, so a regulatory answer, a gap assessment or a drafted submission section rests on the passage it cites.
What the module does
- Search with a question or key phrase, optionally only from chosen issuers: the best passages come back with the document, its code, the page, its status and the official link to read it in full.
- FDA guidance and regulations: 21 CFR Parts 11, 211 and 803, the QMSR, and the guidance on process validation, data integrity, OOS results, aseptic processing, computer software assurance, devices and more.
- ICH quality guidelines Q1 to Q14 with M4Q and M7, and the other ICH guidelines quality work relies on, such as E6(R3) and E9; EU GMP from EudraLex Volume 4, its chapters, Parts II and IV and its annexes, including Annex 1, 11, 15 and 16 and the drafts of the revised Annex 11 and of Annex 22; EMA guidelines and reflection papers; PIC/S PE 009 and PI 041.
- FDA's whole guidance list, read again from FDA's guidance search every Monday: guidance FDA publishes appears in the catalogue, a changed title, date, status or PDF is updated, and guidance FDA withdraws leaves the library. Drug, biologic and medical device guidance is indexed in full in its turn; food, tobacco, veterinary and cosmetics guidance is listed with its official page and PDF.
- A weekly check of every document: each Monday the public documents are downloaded again and re-indexed only when the file changed, and a document whose page has moved or been withdrawn shows the finding. The catalogue gives each document's state (indexed, queued, indexing, not indexed with the reason, or listed) and when it was last checked with the issuer.
- Licensed publications listed, never reproduced: 68 USP general chapters linked to their official USP–NF pages, 38 ASTM standards (pharmaceutical manufacturing and the statistics standards behind control charts, capability, sampling and outlier tests) linked to ASTM's store, ISPE guides including GAMP 5, and PDA technical reports, each shown with a lock and its official link. A USP chapter or ASTM standard cited on a record opens its entry in the library.
- Add your copy: an organization uploads its licensed PDF of a listed publication; it is indexed at once, searchable for that organization's users only, and shown on the catalogue row as its copy.
- Your own reference documents: other documents the organization is licensed to use, added with a title, issuer, code and PDF up to 20 MB, up to 200 per organization.
- Cited inside every answer: Q Intelligence searches the library before it answers a regulatory question, quotes the passage and cites it by code, title and page; a citation check compares every quoted passage with the sources it read and marks a quote it cannot find.
How it fits the platform
The library is the regulatory source for the AI across QLogix. Q Intelligence and Q Agent search it with the records and documents they read; a gap assessment searches it clause by clause and drafts each requirement with its source and link; Statistical Analysis reads each analysis against the guidance a QA statistician cites with it and links to the passage; a regulatory submission's section drafts consult it and name the guidance consulted. Q Intelligence can also hand over the official PDF of a guidance, opened at the issuer, or the organization's licensed copy.
Scheduled agents read the same library, and with an API key the REST API and the MCP server give connected systems and internal agents read-only access to it. An organization's own controlled documents are not part of the library: Q Intelligence searches their effective versions clause by clause and cites them by number, version, section and page.
Where people decide
The library supplies the passages and the AI cites them; people read the passage at its page and decide what it means for their process, record or filing. The organization decides which licensed copies and reference documents to add, and anyone who can write records adds or removes them. No answer, draft or assessment built on the library is a decision: the records it informs are still reviewed, approved and signed by qualified people.
Questions about Regulatory library
Which regulations and guidance are in the library?
FDA guidance and regulations (21 CFR Parts 11, 211 and 803, the QMSR and FDA's guidance list), ICH guidelines (Q1 to Q14, M4Q, M7 and others), EU GMP from EudraLex Volume 4 with its chapters and annexes, EMA guidelines and PIC/S documents, each indexed from the official document with its status and link. USP general chapters, ASTM standards, ISPE guides and PDA technical reports are listed with their official links.
How are AI answers cited?
By document, code and page, with the official link: Q Intelligence searches the library before answering a regulatory question and quotes the passage it relies on. After each answer a citation check compares every quoted passage with the sources it read and marks any quote it cannot find, so a person can check it before relying on it.
Does QLogix reproduce USP, ISPE, PDA or ASTM content?
No. Licensed publications are listed with their official links (USP chapters to their USP–NF pages, ASTM standards to ASTM's store) and no text. An organization that holds a licence uploads its own copy; it is indexed at once and searchable for that organization's users only.
How is the library kept current?
Every Monday each public document is downloaded again and re-indexed only if the file changed, licensed listings have their issuer page checked, and moved or withdrawn documents show the finding. The same check reads FDA's guidance search, so new guidance appears within the week and withdrawn guidance leaves; when FDA's site does not answer, the last list is kept.
Can we add our own documents?
Yes: documents the organization is licensed to use, with a title, issuer, code and PDF up to 20 MB, up to 200 per organization, searchable for its own users. Controlled documents such as SOPs do not need adding: Q Intelligence already searches their effective versions and cites them by number, version, section and page.
How is it licensed?
As a module in the licence, per user per month, ordered by purchase order from the client portal; it is part of the QMS Essentials, Quality Plus, Lab and Root cause investigation suites. Reading guidance through the REST API or the MCP server also needs it.
Other modules
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- Agentic QMSeQMS software for pharma, biotech and medical devices: change control, CAPA and controlled documents on one audited record store, AI drafts and signed decisions.
- Root cause investigationAI-assisted deviation, OOS and complaint investigations beside your existing QMS: 5 Whys and fishbone drafted, each cause tested, a robust root cause and CAPA plan.
- CAPA managementGMP CAPA software: CAPAs opened from investigations, complaints, audits and changes, an AI review of the plan, evidence for each action and an effectiveness check.
- Complaint handlingComplaint handling software for pharma and medical devices: AI triage with quoted evidence, an adverse event check, a route set by QA and the investigation started.