--- title: "Product datasheets: one page per module | QLogix" description: "QLogix product datasheets: a one-page PDF for each module, from complaints, CAPA and change control to LIMS, MES, ERP, validation and Q Intelligence." url: https://qlogix.ai/datasheets markdown: https://qlogix.ai/datasheets.md updated: 2026-10-23 publisher: "QLogix (QLogix LLC)" language: en-US --- # Product datasheets A one-page datasheet for each QLogix product: what it does, where people decide and sign, what it reads across the platform, the frameworks it is built against and how it is licensed, with charts of what the team sees. Share a few details to download a datasheet. ## Intelligence and automation Intelligence and automation ### Q Intelligence Ask across every record, connect your systems, draft the next record for a person to review. Product: [QLogix Q Intelligence and Q Agent](https://qlogix.ai/products/ai-for-pharma-quality) PDF · 1 page · October 2026 Download the PDF Intelligence and automation ### Q Agent Goals worked across every module, from the LIMS and ERP to validation and submissions, inside guardrails: every action waits for a person's approval, and every record drafted goes to its author for review. Product: [QLogix Q Intelligence and Q Agent](https://qlogix.ai/products/ai-for-pharma-quality) PDF · 1 page · October 2026 Download the PDF Intelligence and automation ### Q Dashboard and charts The quality system at a glance, and charts generated from your data, files or a live feed. PDF · 1 page · October 2026 Download the PDF Intelligence and automation ### Regulatory library FDA, ICH and EU GMP with page-level citations, inside every answer. PDF · 1 page · October 2026 Download the PDF Intelligence and automation ### Analytics Trends, capability and the metrics that show whether the system is in control. PDF · 1 page · October 2026 Download the PDF Intelligence and automation ### AI final review Before any record is routed for approval, the AI reads it as the reviewers will and lists what to fix. PDF · 1 page · October 2026 Download the PDF ## Quality events Quality events ### Complaint handling Triage with the adverse-event check, evidence quoted from the complaint, and the decision signed. Product: [QLogix Complaint handling](https://qlogix.ai/products/complaint-handling) PDF · 1 page · October 2026 Download the PDF Quality events ### Root cause investigation Deviation, OOS and complaint investigations with AI-drafted problem statements, hypotheses tested and a robust root cause; on its own beside your existing QMS. Product: [QLogix Root cause investigation](https://qlogix.ai/products/root-cause-investigation) PDF · 1 page · October 2026 Download the PDF Quality events ### CAPA management CAPAs opened from investigations, complaints, audits and changes, with an AI review of the plan, evidence for each action and an effectiveness check. Product: [QLogix CAPA management](https://qlogix.ai/products/deviation-capa-management) PDF · 1 page · October 2026 Download the PDF Quality events ### Batch record review Exceptions found, assessed and dispositioned, with the recommendation signed by QA. Product: [QLogix Batch record review](https://qlogix.ai/products/batch-record-review) PDF · 1 page · October 2026 Download the PDF Quality events ### Signal detection Control charts with run rules on any parameter; each signal interpreted by the AI and dispositioned by QA. PDF · 1 page · October 2026 Download the PDF Quality events ### Backlog triage Open deviations, CAPAs and change controls ranked by risk, with QA's priorities on record. PDF · 1 page · October 2026 Download the PDF ## Quality system and documents Quality system and documents ### Change management Changes to documents, equipment, facilities and utilities under GMP: what changes and how, AI impact and risk assessment, the GMP requirements each item must meet, tasks, approvals to implement, effectiveness and closure. Product: [QLogix Change management](https://qlogix.ai/products/change-control) PDF · 1 page · October 2026 Download the PDF Quality system and documents ### Document management Controlled documents with versions, AI review, approvals, training, effective dates and periodic review; every QMS document in one index. Product: [QLogix Document control](https://qlogix.ai/products/document-control) PDF · 1 page · October 2026 Download the PDF Quality system and documents ### Training The training matrix by job role: controlled documents read and understood with an electronic signature, PDF and PowerPoint material, on-the-job training signed off by the manager and QA, retraining when a document changes, compliance by person. PDF · 1 page · October 2026 Download the PDF Quality system and documents ### Regulatory submissions Changes screened for regulatory impact; NDA and BLA sections drafted from templates. Product: [QLogix Regulatory submissions](https://qlogix.ai/products/regulatory-submissions) PDF · 1 page · October 2026 Download the PDF Quality system and documents ### Risk assessment Design, process, equipment and CSV FMEA with RPN thresholds, mitigation actions and reassessment. Product: [QLogix Risk assessment](https://qlogix.ai/products/quality-risk-management-fmea) PDF · 1 page · October 2026 Download the PDF ## QC laboratory QC laboratory ### LIMS Specifications, samples and results judged by the system, OOS handled under investigation, instruments and standards locked out when out of date, and water systems sampled and tested by point of use. Product: [QLogix LIMS](https://qlogix.ai/products/lims) PDF · 1 page · October 2026 Download the PDF QC laboratory ### Electronic lab notebook Each analytical run recorded as it happens: the effective method, equipment checked across the LIMS, calibration and maintenance, standards and reagents in date, observations never edited, results posted to the LIMS samples. PDF · 1 page · October 2026 Download the PDF QC laboratory ### Environmental Monitoring Contamination control: viable and non-viable monitoring by cleanroom grade, judged against Annex 1 limits, excursions investigated, results trended, each month reviewed and approved. PDF · 1 page · October 2026 Download the PDF QC laboratory ### PM Library A characterized, versioned particulate defect library for fill-finish: inspector qualification kits and AVI challenge sets that stay current. Product: [QLogix PM Library](https://qlogix.ai/products/pm-library) PDF · 1 page · October 2026 Download the PDF QC laboratory ### Stability Study Management ICH stability studies on the LIMS: barcode pulls at the chamber, reminder and escalation emails, and ICH Q1E shelf life computed in seconds by validated code, not Excel or JMP. Product: [QLogix Stability Study Management](https://qlogix.ai/products/stability-study-management) PDF · 1 page · October 2026 Download the PDF ## Manufacturing and equipment Manufacturing and equipment ### Calibration management Every instrument, tool and gauge: an approved requirement, calibrations with readings judged and reviewed by a second person, out-of-tolerance impact signed by QA. PDF · 1 page · October 2026 Download the PDF Manufacturing and equipment ### MES Electronic batch records from your own master batch record: every step executed and verified with credential signatures, entries out of limits flagged, QC samples in the LIMS, orders and consumption with the ERP, release signed by QA. Product: [QLogix MES (electronic batch records)](https://qlogix.ai/products/mes-electronic-batch-records) PDF · 1 page · October 2026 Download the PDF Manufacturing and equipment ### ERP Materials, inventory lots with genealogy and QA's signed release, bills of materials as unit operations, work orders stage by stage to the finished lot, scheduling, budgets and the material plan; released lots lock dispensing in the MES. PDF · 1 page · October 2026 Download the PDF Manufacturing and equipment ### GMP logbooks Clean room, equipment and instrument logbooks kept as signed entries, with the periodic review the system checks first. Product: [QLogix GMP logbooks](https://qlogix.ai/products/gmp-electronic-logbooks) PDF · 1 page · October 2026 Download the PDF Manufacturing and equipment ### CMMS Assets with preventive plans and work orders verified for return to service; reliability, lifecycle and predicted failures from the history. PDF · 1 page · October 2026 Download the PDF ## Validation, projects and security Validation, projects and security ### Validation Plans, URS, risk assessments, protocols and reports from Part 11-ready templates, with GAMP 5 and CSA scaling the effort. Product: [QLogix Validation](https://qlogix.ai/products/computer-system-validation) PDF · 1 page · October 2026 Download the PDF Validation, projects and security ### Operational excellence A3s, kaizen, value stream maps, 5S, standard work, SQDIP boards, bowlers and policy deployment, computed by the system and coached by the AI; your own CI applications; OPEX projects in their own series. PDF · 1 page · October 2026 Download the PDF Validation, projects and security ### Project management Programs and projects on audited records: work breakdown, resources, risks, baseline, critical path and earned value. PDF · 1 page · October 2026 Download the PDF Validation, projects and security ### Security and Part 11 Hash-chained audit trails, electronic signatures with password re-entry, access levels and a security log on every record. PDF · 1 page · October 2026 Download the PDF Each download link works once, for the datasheet requested. Your details go to the QLogix team only; see the [Privacy Policy](https://qlogix.ai/privacy). Looking for the longer reads? See the [white papers](https://qlogix.ai/whitepapers). ## 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 show you that investigation drafted on the operating system, and tell you plainly what we would move 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 - The systems you run today (QMS, MES, LIMS, ERP, CMMS) and which could run on one operating system - Where investigations, CAPAs and change assessments slow down, and what AI drafting would change - Where to start, and whether a readiness assessment makes sense ## More from QLogix - [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. - [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/datasheets Cite this page as https://qlogix.ai/datasheets QLogix · contact@qlogix.ai · +17146639012