---
title: "Regulatory gap assessment against FDA, EU GMP and ICH | QLogix"
description: "Gap assessments against FDA, EU GMP, ICH and PIC/S: every requirement cited from the regulatory library, rated, remediated with evidence and closed with signatures."
url: https://qlogix.ai/products/regulatory-gap-assessment
markdown: https://qlogix.ai/products/regulatory-gap-assessment.md
updated: 2026-10-30
publisher: "QLogix (QLogix LLC)"
language: en-US
---

# Regulatory gap assessment for GMP: requirements cited, gaps rated, remediation tracked and closure signed
The QLogix Gap assessment module compares the existing state of a process, computerized system, procedure, quality system, facility, laboratory, supplier or validation (equipment, process, computerized system, cleaning, facility and utility) with the regulatory requirements that apply to it, clause by clause, on audited, signed records. The team states the scope and intent in its own words, chooses the frameworks and describes the existing state with its evidence. The AI searches the regulatory library for the clauses each framework holds on the subject and drafts a complete register: every requirement with its source, what the existing state shows, a rating, the severity of each finding and its remediation. The team re-rates with reasons, assigns owners, approves the assessment, tracks each remediation to its evidence and closes the record with signatures.
[Request a demo](https://qlogix.ai/contact)[All products](https://qlogix.ai/products)

## What the module does
- Seven subject types, each with its frameworks preselected: a process, a computerized system, a procedure or document, a quality system, a facility, equipment or utility, a laboratory, and a supplier or outsourced activity.
- Up to twelve frameworks per assessment, among them 21 CFR Parts 11, 210 and 211, 600 to 680 and 820; FDA guidance on data integrity, process validation, computer software assurance, OOS results and the quality systems approach; EU GMP Parts I and II with Annexes 1, 11, 15 and 16 and the GDP guidelines; ICH Q7 to Q10, Q12, Q2 and Q14; and PIC/S PI 041 and PE 009. Other standards and corporate or client requirements are stated in words.
- The scope and intent written by the team: what to compare with what, why, and the decision the assessment informs, such as an inspection, a remediation plan, a procedure revision or a transfer. The AI keeps to it.
- Evidence of the existing state: the controlled documents already in QLogix, read at their effective version; linked validation projects, risk assessments, change controls, CAPAs and investigations; and files (PDF, Word, Excel, CSV, text and images), each fingerprinted on arrival.
- AI research clause by clause: several focused searches of the regulatory library per framework, the clauses it cites read, the evidence read, and the register drafted with an overall conclusion, the strengths, the assumptions made where the record was silent, the questions to settle before approval and the sources read with their official links.
- A complete register, not a list of problems: every requirement is a row, including the ones met, with the clause, its source by code, title, clause and page, what the existing state shows and the evidence it rests on, a rating (Compliant, Partially compliant, Gap, Not applicable or Not assessed) and the rationale.
- Findings graded Critical, Major, Minor or Observation, each with its remediation, an owner and a due date. A re-rating always needs a reason, and the overall conclusion moves with it.
- Remediation tracked to its evidence: owners emailed their finding, statuses from Open to Done with evidence and Verified effective, evidence files such as the revised procedure or the change control closure linked to the finding, and minor gaps or observations accepted only with a justification.
- Assessment approval as a signed milestone, then a signed closure that locks the record, and the gap assessment report exported as a locked PDF.

## How it fits the platform
A gap assessment reads the organization's own controlled documents from document control at their effective version and links the validation projects, risk assessments, change controls, CAPAs and investigations that bear on the subject. The remediation of a finding is often done in another module, and its evidence comes back to the finding: the revised procedure, the change control closure, a test report or a training record.
Q Intelligence lists and reads gap assessments, with their conclusion, findings by severity and open and overdue remediations, and can open one from a conversation with the form prefilled for a person to review and create. Q Agent proposes opening or running an assessment as an action that waits for approval. The document hub indexes every gap assessment with its stage, and the audit trail export covers gap assessments under their own area.

## Where people decide
The AI researches the frameworks and drafts the register: the requirements, the ratings, the severities and the remediation, each row citing its source. The team settles every row, re-rates with a reason, provides the evidence for anything not assessed, names the owners and due dates and decides which minor gaps and observations are accepted with a justification. The owners record the remediation and its evidence, and the approvers sign the assessment approval and the closure.

## Where people decide
- Assessment approval needs every requirement rated, every finding with its severity, rationale and remediation or justified acceptance, and every Critical and Major gap with an owner and a due date.
- A Critical or Major gap cannot be accepted as it stands: it is remediated with its evidence, and a Critical gap is verified effective before closure.
- Closure records the outcome (gaps closed, residual gaps accepted, or remediation incomplete, which keeps the record open) and a closure summary, and its signature locks the record.

## Built to
- 21 CFR Parts 210 and 211
- 21 CFR Part 11 and EU GMP Annex 11
- EU GMP Part I and Annex 15
- ICH Q9(R1) and ICH Q10
- PIC/S PI 041 data integrity guidance
- FDA guidance on the quality systems approach to pharmaceutical CGMP regulations

## Licensing
Per user per month, on its own or with other modules, ordered by purchase order from the client portal. Every module writes to the same audited records.
[Ask for a quote](https://qlogix.ai/contact)

## Questions about Gap assessment

### What is a regulatory gap assessment?

A gap assessment compares the existing state of a process, system or procedure with the regulatory requirements that apply to it, and records where it falls short and how each shortfall will be remediated. In QLogix every requirement is a row, including the ones met, so the register shows what complies as well as what does not, each row citing its clause and source.

### Which regulations can a gap assessment cover?

FDA regulations and guidance, EU GMP Parts I and II with Annexes 1, 11, 15 and 16 and the GDP guidelines, ICH quality guidelines and PIC/S PI 041 and PE 009, among others, up to twelve frameworks per assessment. GAMP 5, ISO 13485 and 14971, the EU MDR and IVDR, WHO GMP and the USP general chapters can be chosen too; unless the organization added its licensed copy to the regulatory library, they are assessed from the standard's structure and each row says so. Other standards and corporate or client requirements are stated in words.

### How does the AI find the requirements?

It reads the scope and intent, runs several focused searches of the regulatory library per framework, reads the clauses it cites and then reads the evidence: the description, the files, the linked records and the effective controlled documents. Each row gives its source by code, title, clause and page with the official link, and the assessment lists the regulatory sources read. The team checks and re-rates any row, always with a reason.

### Can it assess a computerized system against Part 11 and Annex 11?

Yes. A computerized system assessment preselects 21 CFR Part 11, EU GMP Annex 11, the FDA data integrity questions and answers, PIC/S PI 041, GAMP 5 and FDA computer software assurance guidance. The team describes the system's controls and records, attaches its validation documents or links the validation project, and the AI rates each requirement against that evidence.

### How are gaps remediated and closed?

Each finding gets an owner, who is emailed the finding, its source, the remediation and the due date. The owner records it Done with evidence, as a description or an attached file, and a Critical gap is then verified effective. Closure needs every finding settled and the outcome and closure summary recorded; it is signed, the record is locked, and the report is exported as a locked PDF.

### How is it licensed?

Per user per month, on its own or with other modules, ordered by purchase order from the client portal. AI use is included in the licence. There is no card payment or self-serve plan.

## Reading
- [Computer software assurance: what FDA's final guidance changes for validationFDA's final guidance on computer software assurance replaces test-everything validation with effort matched to risk. Features that could compromise safety get scripted testing; the…](https://qlogix.ai/blog/computer-software-assurance-final-guidance)

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Source: https://qlogix.ai/products/regulatory-gap-assessment
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