--- title: "AI final review of GxP records before approval | QLogix" description: "Before a GxP record is routed for approval, the AI reads it as the reviewers will and lists must-fix, should-fix and consider findings, each with a suggested fix." url: https://qlogix.ai/products/ai-final-review markdown: https://qlogix.ai/products/ai-final-review.md updated: 2026-10-30 publisher: "QLogix (QLogix LLC)" language: en-US --- # AI final review for GxP records: a reviewer's reading before approval, with what to fix and how The QLogix AI final review is a last due-diligence pass on a GxP record before its author routes it for review and approval. The AI reads the whole record as the reviewers, the approvers and later an inspector will, against what its record type must contain and the review cycle it is heading for, and gives a verdict with up to 25 findings, each marked must fix, should fix or consider, with the place, the issue, the record's own words and a suggested fix. It changes nothing in the record: the author fixes what they accept, then runs it again or submits. Every run is an entry in the record's audit trail on the version it reviewed, and the submission records whether must-fix findings were left open. [Request a demo](https://qlogix.ai/contact)[All products](https://qlogix.ai/products) ## What the module does - Runs from the Review and approval panel of any record with review and approval, while the record is a draft or heading for its next review cycle; a record in review, signed or cancelled is not reviewed. - Reads the record against the standards a reviewer applies: complete (no placeholders, empty tables or unexplained not-applicables), consistent (dates, numbers, names, lots, references and conclusions agree), specific and attributable (who does what by when, evidence named rather than asserted), compliant with what the record type requires under GMP, including data integrity, and clear to a reader outside the team. - Gives a verdict (Ready to submit, Ready after the changes below, or Not ready) with up to 25 findings as must fix, should fix or consider, each with the place in the record, the issue, the record's own words where there are any and a suggested fix, plus what is done well and should stay. - Checks what each record type must contain: a controlled document's scope and steps, a change control's impact assessment and plan, a CAPA's root cause and effectiveness criterion, an investigation's evidence and conclusion. - For an investigation, that the conclusion follows from the evidence, that ruled-out hypotheses are ruled out by data, that the root cause is not "human error" without the condition behind it, and that the scope of impact was assessed rather than assumed. - For a complaint, that the fields agree with the complaint text, that any mention of harm or a patient is reflected in the adverse event assessment, and that the decision matches what was reported; for a batch record review, unanswered items and exceptions without a resolved reference. - Works beside the system's readiness checks, which list what the cycle still needs and refuse a submission while anything is left: the AI is told what they found and looks for what lies behind it instead of repeating it. - Judges only from the record: it does not invent facts about the product, site or process, and where the record needs information it does not hold, the finding says what is needed and where. - Tied to the version it read: the panel says when the record has changed since the run, and each run is an audit trail entry with the verdict and the findings, while the record's content and version stay as they were. ## How it fits the platform The final review is a step in the review and approval workflow every QLogix record shares: a named author, reviewers and approvers, readiness, the AI final review, then electronic signatures in the order the author chooses. It reads complaints, investigations, CAPAs, change controls, controlled documents and batch record reviews, and the other records routed for approval across the platform, from validation documents and risk assessments to regulatory submissions and laboratory records. When Q Agent or a scheduled agent creates a record, the record is filled from the source records, the product's AI drafting runs on it, and the AI final review reads it as a reviewer would before it is handed to its author. The author sees which agent drafted the record and, below it, the final review's list of what to fix, then reviews, edits and routes it. ## Where people decide The AI reads and reports; the author decides. Fixing a finding is the author's edit, recorded in the audit trail as theirs, and open must-fix findings do not stop a submission: the author may submit, and the submission records whether it followed a current review, an earlier version's review, no review, or must-fix findings left open by the author's decision. Reviewers and approvers then sign with their own credentials; the AI never reviews, approves or signs in their place. ## Where people decide - The author decides which findings to act on; the AI changes nothing in the record. - A submission with must-fix findings open is the author's recorded decision, written to the audit trail with the review's state on that version. - Reviewers and approvers sign with their own credentials; the AI's verdict is an input to their review, never a signature. ## Built to - 21 CFR 211 and 21 CFR 820 (QMSR) - ICH Q9(R1) and ICH Q10 - 21 CFR Part 11 and EU GMP Annex 11 - EU GMP Chapter 4 documentation - PIC/S PI 041 data integrity - Draft EU GMP Annex 22 on artificial intelligence ## 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 AI final review ### What does an AI final review check? Whether the record is complete, consistent, specific, compliant with what its type requires under GMP and clear, read as the reviewers and an inspector will. It also checks what the record type must contain, such as a CAPA's root cause and effectiveness criterion or an investigation's evidence and conclusion, and reports each finding with its place, the record's words and a suggested fix. ### Does the AI change or approve the record? No. It reports findings and a verdict; the author decides what to fix and makes the edits. Reviewers and approvers sign with their own credentials, and the run itself is only an audit trail entry on the version it read. ### Can a record be submitted with must-fix findings open? Yes, by the author's decision, and the submission records it. The audit trail says whether the record was submitted after a current final review, after a review of an earlier version, without a review, or with must-fix findings left open. ### How is it different from the readiness checks? Readiness is the system's own rule check: it lists what the review cycle still needs, such as a decision on every CAPA or an effective date on a document, and refuses a submission while anything is left. The AI final review reads the content as a reviewer would, and is told what readiness found so it looks behind it rather than repeating it. ### Which records does it review? Any record routed for review and approval: complaints, investigations, CAPAs, change controls, controlled documents and batch record reviews, and records across the platform such as validation documents, risk assessments, regulatory submissions and laboratory records. Records that Q Agent and scheduled agents create are reviewed before they are handed to their author. ### How is it licensed? It is not licensed separately. It comes with each module whose records are routed for review and approval and runs under that module's licence, for anyone permitted to use the AI. ## Reading - [Connecting LIMS to investigations and CAPA: how AI speeds up OOS investigations and strengthens complianceMost OOS investigations lose their first days to gathering: the result, the raw data, the instrument's calibration, the standard's expiry, the analyst's history, the trend. When th…](https://qlogix.ai/blog/lims-investigation-capa-integration-ai) - [EU GMP Annex 22: what the draft AI annex asks of GMP manufacturersDraft Annex 22 is the first GMP annex written for AI. It allows static, deterministic models in critical GMP applications, keeps generative AI out of them, and asks for a defined i…](https://qlogix.ai/blog/eu-gmp-annex-22-ai-draft) ## Other modules - [Regulatory libraryFDA, ICH, EU GMP, EMA and PIC/S guidance indexed from the official documents, so every AI answer cites the code and page. USP and ASTM listed, never reproduced.](https://qlogix.ai/products/regulatory-library) - [Q Dashboard and chartsThe quality system at a glance: open records, what needs attention, age and cycle time, charts from your data or a live feed, and periodic reports as locked PDFs.](https://qlogix.ai/products/quality-dashboard-and-charts) - [AnalyticsGMP statistics on audited records: control charts with run rules, capability, CPV, ICH Q2 method validation, ICH Q1E shelf life, Gage R&R and DOE, signed as a PDF.](https://qlogix.ai/products/statistical-analysis-trending) - [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.](https://qlogix.ai/products/agentic-qms) - [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.](https://qlogix.ai/products/root-cause-investigation) - [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.](https://qlogix.ai/products/deviation-capa-management) [All 33 product pages](https://qlogix.ai/products) ## More from QLogix - [Agentic QMS](https://qlogix.ai/products/agentic-qms.md): eQMS 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 investigation](https://qlogix.ai/products/root-cause-investigation.md): AI-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 management](https://qlogix.ai/products/deviation-capa-management.md): GMP 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 handling](https://qlogix.ai/products/complaint-handling.md): Complaint 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. - [Batch record review](https://qlogix.ai/products/batch-record-review.md): Batch record review software that reviews by exception: the AI lists only the exceptions with quotes, QA dispositions each one and signs the release recommendation. - [Batch release](https://qlogix.ai/products/lot-release.md): Batch release software for GMP manufacturing: the batch record, QC results against specification and every quality event checked before QA signs the disposition. - [Change management](https://qlogix.ai/products/change-control.md): GMP change management software for document, equipment and facility changes: AI impact and ICH Q9 risk assessment, GMP requirements per item, approval and closure. - [Document control](https://qlogix.ai/products/document-control.md): Document control software for GMP: AI review of each SOP draft, signed approval on an effective date, read-and-understood training signatures and periodic review. - [Training](https://qlogix.ai/products/gmp-training-management.md): GMP training management: a training matrix by job function, SOPs read and understood with a Part 11 signature, OJT signed by manager and QA, retraining on change. - [Risk assessment](https://qlogix.ai/products/quality-risk-management-fmea.md): Quality risk management software for FMEA under ICH Q9(R1): design, process, equipment and CSV templates, RPN thresholds, mitigation tracked to residual risk. - [Regulatory submissions](https://qlogix.ai/products/regulatory-submissions.md): Regulatory submissions software: post-approval changes screened per market, NDA and BLA sections drafted on an eCTD template, every claim quoted from its source. - [Gap assessment](https://qlogix.ai/products/regulatory-gap-assessment.md): 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. - [QLogix home](https://qlogix.ai/index.md): AI-native GxP operating system for life sciences manufacturers: AI drafts investigations, CAPAs and change assessments from quoted evidence; people review and sign. - [Services](https://qlogix.ai/services.md): QLogix services that bring the GxP operating system live: digitized records, AI-assisted investigations, connected data, validated AI and agentic workflows. - [Products](https://qlogix.ai/products.md): QLogix modules on one record store: eQMS, CAPA and deviations, complaints, change and document control, LIMS, ELN, MES and batch records, ERP, CMMS and validation. - [Blog](https://qlogix.ai/blog.md): QLogix blog: regulatory updates on AI in GxP, FDA and EU guidance explained, and how life sciences quality teams adopt and validate AI. - [White papers](https://qlogix.ai/whitepapers.md): QLogix white papers: AI investigations, agentic QMS, FMEA, regulatory submissions, complaints, LIMS and CMMS, validation and particulate inspection. - [Datasheets](https://qlogix.ai/datasheets.md): QLogix product datasheets: a one-page PDF for each module, from complaints, CAPA and change control to LIMS, MES, ERP, validation and Q Intelligence. - [Request a meeting](https://qlogix.ai/contact.md): Talk to QLogix about the AI-native GxP operating system: AI-drafted investigations, CAPAs and change assessments, implementation, migration and validation. - [llms.txt: a summary of the site for AI assistants](https://qlogix.ai/llms.txt) - [Site map](https://qlogix.ai/sitemap.md) --- Source: https://qlogix.ai/products/ai-final-review Cite this page as https://qlogix.ai/products/ai-final-review QLogix · contact@qlogix.ai · +17146639012