AI QMS software for life sciences, module by module
QLogix is one eQMS and operations platform for pharma, biotech, CDMOs, medical devices and 503B facilities: deviations and CAPA, complaints, change control, document control, LIMS, electronic batch records, calibration, maintenance and validation on one set of audited records, with AI that drafts and flags while qualified people decide and sign. Each module is licensed on its own or with the others.
Agentic QMS: the platform that joins every moduleeQMS software for pharma, biotech and medical devices: change control, CAPA and controlled documents on one audited record store, AI drafts and signed decisions.Quality events
Deviations, OOS results, complaints and batch records, investigated and closed with the evidence on the record.
- Investigations and CAPAsCAPA software with deviation and OOS investigations: AI-drafted 5 Whys and fishbone, each cause tested as a hypothesis, CAPAs closed on an effectiveness check.
- Complaint handlingComplaint 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 reviewBatch record review software that reviews by exception: the AI lists only the exceptions with quotes, QA dispositions each one and signs the release recommendation.
Documents, change and risk
The controlled documents, changes, risk assessments and regulatory filings that keep the validated state.
- Change controlChange control software for GMP: AI impact assessment in nine areas with ICH Q9 risk, tasks by function, signed approval to implement, effectiveness and closure.
- Document controlDocument control software for GMP: AI review of each SOP draft, signed approval on an effective date, read-and-understood training signatures and periodic review.
- Risk assessmentQuality risk management software for FMEA under ICH Q9(R1): design, process, equipment and CSV templates, RPN thresholds, mitigation tracked to residual risk.
- Regulatory submissionsRegulatory submissions software: post-approval changes screened per market, NDA and BLA sections drafted on an eCTD template, every claim quoted from its source.
Laboratory, manufacturing and equipment
The lab, the production floor and the equipment, on the same records as quality.
- LIMSLIMS for pharma QC laboratories: approved specifications, results judged by the system, OOS under investigation, calibration lockouts and a signed CoA.
- Electronic lab notebookAn ELN for the QC laboratory: effective methods, equipment checked across LIMS, calibration and CMMS, observations never edited, results posted to the LIMS.
- MES (electronic batch records)MES for pharma with electronic batch records: your master batch record, every step signed and verified, review by exception, ERP orders and QA release.
- GMP logbooksElectronic logbooks for GMP cleanrooms, equipment and instruments: system-stamped entries, second-person verification, never edited, periodic reviews signed.
- PM LibraryA particulate matter library for fill-finish: defects characterized with images and FTIR, approved by QA, and current kits for inspector and AVI qualification.
- Calibration managementEvery instrument, tool and gauge: an approved requirement, readings judged by the system and reviewed by a second person, out-of-tolerance impact signed by QA.
- CMMSA GMP CMMS on audited records: assets with preventive plans, work orders verified for return to service, and reliability and predicted failures from the history.
Validation and projects
Computer system validation and the projects that deliver it, on schedule and on the record.
- ValidationComputer system validation software built on GAMP 5 and CSA: URS and risk, IQ/OQ/PQ protocols, electronic test execution, a live traceability matrix, signed reports.
- Project managementPrograms and projects on audited records: AI-drafted plans with work breakdown, resources, risks, baseline, critical path and earned value, signed at approval.
AI for quality
Answers, drafts and agents across every record, with a person approving every action.
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.
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