Documentation
QLogix operating manual
How to use every product in the QLogix portal: what each one is for, the procedure step by step, who decides what, the rules the system enforces, and how records flow from one product to the next.
Last updated · 25 chapters
How to read the flow diagrams
Each procedure is drawn as numbered steps. The badge on each step says who does it. The AI never decides: it drafts for a person to review, and only people approve and sign.
- Person: you decide or act
- AI drafts: a draft for review
- System: automatic
- E-signature: email and password re-entry
Every record follows the same pattern: a person starts it, the AI drafts, people decide and edit with reasons, and approvers sign. Records link to each other in both directions.
- Person
1. Event detected
Complaint, deviation, OOS, signal, batch exception or audit finding
- System
2. Record created
Numbered, hash-chained audit trail starts
- AI drafts
3. AI draft
Triage, root cause analysis, assessment, with quoted evidence
- Person
4. Review and decide
Edit with reasons, disposition each item, test hypotheses
- Person
5. Route for approval
Reviewers and approvers by role; content frozen
- E-signature
6. Sign
Email and password re-entry
- Person
7. Follow-up records
CAPA, change control, document revision, submission
- System
8. Trend and verify
Dashboard, charts, signals, effectiveness checks
- A reviewer or approver can return the record; the author can withdraw it. It goes back to draft and can be edited again.
- A signed record is locked. Reopening it needs a reason, and the earlier signature stays in the audit trail.
Getting started
- Getting startedSign in, find your way around the portal, understand what the AI does and what people decide, and learn the pattern every record follows.Read the chapter
- Records, review and signaturesThe procedures shared by every record: editing with reasons, attachments, connected records, routing for review and approval, electronic signatures, reopening, cancelling and controlled exports.Read the chapter
- Demo workspaceLoad a connected example story across every product, a particle complaint that runs through investigation, batch review, trending, CAPA, change control, document control and regulatory impact, and follow the presenter's script.Read the chapter
Quality events
- Complaint handlingLog a complaint as received, let the AI draft the complaint record with quoted evidence, decide the route (pharmacovigilance, investigation, trend only or close), confirm receipt to the reporter, and draft the preliminary evaluation that starts the investigation.Read the chapter
- Investigations and root causeOpen an investigation from a deviation, OOS, complaint or audit finding; let the AI draft the problem statement, containment, 5 Whys, fishbone and CAPA plan from your write-up and documents; test each fishbone cause as a hypothesis; reach a robust conclusion and hand the CAPA to the QMS.Read the chapter
- Batch record reviewAttach an executed batch record or paste an extract; the AI reviews it against the master record and limits and lists only the exceptions. You disposition each exception, link deviations and record a signed recommendation; batch disposition stays in your QMS.Read the chapter
- Signal detectionPaste batch, lab, environmental or equipment results; fixed statistical rules find limit breaches, shifts, trends and unusual variation, the AI explains each signal, and QA dispositions them and records a signed recommendation.Read the chapter
Agentic QMS
- Agentic QMS and work queueChange control, CAPA and document control on the same audited records as every other product, with derived workflow stages, a work queue across every product and a record graph in both directions.Read the chapter
- Change controlPropose a change, let the AI assess impact across nine areas and the ICH Q9 risk with quoted evidence, plan the tasks, get approval to implement, complete the tasks with evidence, verify effectiveness and close.Read the chapter
- CAPAOpen a corrective or preventive action from an investigation, finding or trend; let the AI review the plan for adequacy; approve the plan; complete the actions with evidence; check effectiveness and close.Read the chapter
- Document controlCreate a controlled document, let the AI review each draft version, disposition findings, approve the version and make it effective on a date, collect read-and-understood training signatures, and manage periodic review and obsolescence.Read the chapter
Regulatory and validation
- ValidationPlan, execute and document equipment, facility and utility, process, cleaning and computer system validation: an AI-drafted plan with pre-execution activities, owners and due dates; protocols and reports from Part 11-ready templates; results, deviations, approvals and closure.Read the chapter
- Regulatory submissionsScreen a change for regulatory impact with a suggested reporting route per market, confirm each route as regulatory affairs, then draft submission sections in which every claim is sourced to a document and verified.Read the chapter
- Backlog triageRank open deviations, CAPAs, change controls, complaints and findings by risk with the reason for each flag; QA sets every priority and signs the order to work the queue.Read the chapter
Intelligence and automation
- Q IntelligenceThe hub of the quality system: ask about any record, document, audit trail or regulation, draft the next record for review, chart and analyse data, build FMEAs, and hand work to Q Agent. It cites its sources and remembers your conversations.Read the chapter
- Q Agent and alertsHand Q Agent a goal and it works it across the QMS (logs complaints, opens investigations, drafts root cause analyses, runs triage and signal detection, flags, emails and schedules), waiting for your approval. Alerts tell the right people when a record needs them.Read the chapter
- Agent runnerScheduled agents read your records, write a report and propose emails or flags for your approval: daily huddle prep, overdue CAPA chasing, APR/PQR data packs, QMS gap watch, management review and inspection readiness.Read the chapter
- Regulatory libraryFDA guidance and regulations, ICH quality guidelines, EU GMP, EMA and PIC/S, indexed from the official documents so Q Intelligence and Q Agent answer with page-level citations. Add your licensed ISPE and PDA copies.Read the chapter
Trending and analysis
- Q DashboardYour quality system at a glance: open, in-progress and closed records by area, what needs attention, the age of open records, records opened per month, and the charts you pinned for routine trending.Read the chapter
- Control charts and capabilityTrend process and analytical results on an individuals and moving range chart, with alert limits at 2 sigma, action limits at 3 sigma, run rules, specification lines and process capability, then save the chart for routine trending on your dashboard.Read the chapter
- Data analysis and statisticsUpload a CSV or Excel file and ask Q Intelligence for the chart that shows the trend, test data for normality with p-values, and run statistical hypothesis tests (t-tests, Mann-Whitney, ANOVA, Fisher's exact, chi-square).Read the chapter
- FMEA and PFMEABuild an FMEA, PFMEA or DFMEA from your records: failure modes scored for severity, occurrence and detection, ranked by RPN, classed Critical to Low, with mitigation actions and residual RPN for every Critical and High risk, exported to Excel.Read the chapter
Administration and compliance
- Settings, users and numberingYour profile and alert emails, and for administrators: inviting people, access levels, deactivation, and the numbering format of each record series.Read the chapter
- Security and auditHow records are protected: the append-only, hash-chained audit trail and its integrity check, reasons for change, electronic signature controls, session limits, tenant segregation, the security event log and audit-trail review and export.Read the chapter
- API and integrationsConnect other systems: API keys with read or Q Agent task scopes, the read-only REST API with its OpenAPI description, the MCP server for AI assistants, and tool connectors Q Intelligence can call.Read the chapter