# White papers One-page briefs for quality, regulatory and operations leaders on putting AI to work in a GxP quality system, each with its sources, charts and the controls that keep decisions with qualified people. Share a few details to download a paper. InvestigationsRoot cause analysisCAPA ## From deviation to defensible root cause AI-enabled investigations for GxP manufacturing Why inadequate investigations remain among FDA's most frequent observations, and how an AI-drafted analysis, hypothesis testing and an 11-point root cause check keep every decision with the investigator. PDF · 1 page · October 2026 Download the PDF Agentic QMSArchitectureAI agents ## One quality system, one AI layer The case for an Agentic QMS What separate quality systems cost in validation, interfaces and oversight, and how one compliant record layer lets AI agents see the whole quality system and act only with a person's approval. PDF · 1 page · October 2026 Download the PDF Quality risk managementFMEAICH Q9(R1) ## Risk assessments that stay true to the data Q Intelligence and the AI-enabled FMEA Quality risk management under ICH Q9(R1): occurrence and detection scored from the organization's own records, every Critical and High risk followed up, and the residual risk accepted on evidence. PDF · 1 page · October 2026 Download the PDF Regulatory affairsNDA and BLAPost-approval changes ## From change control to filed dossier AI-enabled regulatory submissions on an Agentic QMS Post-approval changes screened for five markets, NDA and BLA dossiers checked against a 62-section eCTD template, and submission text in which every claim quotes its source. PDF · 1 page · October 2026 Download the PDF Complaint handlingInvestigationsBacklog ## From complaint to closed CAPA, with nothing left behind An Agentic QMS for complaints, investigations and backlog The reporting clocks a complaint can start, how AI triage hands each complaint to an investigation with its evidence, and how a risk-ranked backlog puts the oldest serious records first. PDF · 1 page · October 2026 Download the PDF LIMSCalibrationLogbooksCMMS ## Lab and plant, connected LIMS, calibration, logbooks and CMMS on one AI-enabled infrastructure How shared records turn GMP dependencies into rules: no result on an out-of-calibration instrument, calibration failures feeding maintenance reliability, and logbook reviews the system checks first. PDF · 1 page · October 2026 Download the PDF ValidationCSV and GAMP 5Project management ## Validation, digitized and on schedule Electronic validation with project management built in Eighteen templated validation documents on the V-model, electronic test execution with traceability, and a schedule that reports every day whether the validation project is on track. PDF · 1 page · October 2026 Download the PDF Each download link works once, for the paper requested. Your details go to the QLogix team only; see the [Privacy Policy](https://qlogix.ai/privacy). ## Talk it through with someone who has run a plant Bring your backlog, your systems map or one investigation that keeps coming back. We will tell you plainly what we would do and what we would leave alone. [Request a meeting](https://qlogix.ai/contact)[Email us](mailto:contact@qlogix.ai) In the first meeting we cover - Your current QMS and how it connects to MES, LIMS and ERP - Where deviations, CAPAs and change controls slow down - Whether a readiness assessment makes sense, and what it would cover --- Source: https://qlogix.ai/whitepapers QLogix · contact@qlogix.ai · +17146639012