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
PDF · 1 page · October 2026
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 automationQ 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
PDF · 1 page · October 2026
Intelligence and automationQ 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
Intelligence and automationRegulatory library
FDA, ICH and EU GMP with page-level citations, inside every answer.
PDF · 1 page · October 2026
Intelligence and automationAnalytics
Trends, capability and the metrics that show whether the system is in control.
PDF · 1 page · October 2026
Intelligence and automationAI 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
Quality events
Quality eventsComplaint handling
Triage with the adverse-event check, evidence quoted from the complaint, and the decision signed.
Product: QLogix Complaint handling
PDF · 1 page · October 2026
Quality eventsRoot 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
PDF · 1 page · October 2026
Quality eventsCAPA 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
PDF · 1 page · October 2026
Quality eventsBatch record review
Exceptions found, assessed and dispositioned, with the recommendation signed by QA.
Product: QLogix Batch record review
PDF · 1 page · October 2026
Quality eventsSignal detection
Control charts with run rules on any parameter; each signal interpreted by the AI and dispositioned by QA.
PDF · 1 page · October 2026
Quality eventsBacklog triage
Open deviations, CAPAs and change controls ranked by risk, with QA's priorities on record.
PDF · 1 page · October 2026
Quality system and documents
Quality system and documentsChange 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
PDF · 1 page · October 2026
Quality system and documentsDocument management
Controlled documents with versions, AI review, approvals, training, effective dates and periodic review; every QMS document in one index.
Product: QLogix Document control
PDF · 1 page · October 2026
Quality system and documentsTraining
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
Quality system and documentsRegulatory submissions
Changes screened for regulatory impact; NDA and BLA sections drafted from templates.
Product: QLogix Regulatory submissions
PDF · 1 page · October 2026
Quality system and documentsRisk assessment
Design, process, equipment and CSV FMEA with RPN thresholds, mitigation actions and reassessment.
Product: QLogix Risk assessment
PDF · 1 page · October 2026
QC laboratory
QC laboratoryLIMS
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
PDF · 1 page · October 2026
QC laboratoryElectronic 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
QC laboratoryEnvironmental 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
QC laboratoryPM Library
A characterized, versioned particulate defect library for fill-finish: inspector qualification kits and AVI challenge sets that stay current.
Product: QLogix PM Library
PDF · 1 page · October 2026
QC laboratoryStability 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
PDF · 1 page · October 2026
Manufacturing and equipment
Manufacturing and equipmentCalibration 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
Manufacturing and equipmentMES
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)
PDF · 1 page · October 2026
Manufacturing and equipmentERP
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
Manufacturing and equipmentGMP logbooks
Clean room, equipment and instrument logbooks kept as signed entries, with the periodic review the system checks first.
Product: QLogix GMP logbooks
PDF · 1 page · October 2026
Manufacturing and equipmentCMMS
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
Validation, projects and security
Validation, projects and securityValidation
Plans, URS, risk assessments, protocols and reports from Part 11-ready templates, with GAMP 5 and CSA scaling the effort.
Product: QLogix Validation
PDF · 1 page · October 2026
Validation, projects and securityOperational 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
Validation, projects and securityProject management
Programs and projects on audited records: work breakdown, resources, risks, baseline, critical path and earned value.
PDF · 1 page · October 2026
Validation, projects and securitySecurity 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
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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.
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