Close deviations and CAPAs faster, without loosening control.
QLogix delivers AI transformation for life sciences quality. We select, configure, validate and connect quality management systems for biotech, pharma, CDMOs and 503B facilities, then add AI workflows that draft, trend and flag, while qualified people review and approve.
Designed around
- 21 CFR Part 11
- EU GMP Annex 11
- GAMP 5 (2nd ed.)
- ICH Q10
Platform-agnostic. We implement and integrate with your existing quality management system.
Quality systems that record everything and connect nothing
Most sites we see run a capable QMS next to MES, LIMS and ERP systems that never talk to it. The cost shows up in the same places every time.
Investigations that start from a blank page
Each deviation is written up from scratch, so quality varies by author and cycle time depends on who is available.
Try the simulationBacklogs that age quietly
Open deviations, CAPAs and change controls pile up without a clear view of which ones carry risk.
Try the simulationSignals found after the batch
Trends sit across batch records, lab results and complaints. Nobody sees the pattern until it becomes a recurrence.
Try the simulation
See it work
Nine short simulations with illustrative data. Each one shows AI doing the groundwork while your people make the call.
From a blank page to an approved CAPA
Illustrative dataAI drafts one candidate per category from the evidence.
Method
Machine
Material
DEV-0139 · problem
Particulates found at visual inspection
Sterile fill, line 2
Measurement
People
Environment
The AI drafts candidates and the CAPA. Your investigator and QA make every decision.
Want to see this with your own systems and data?
Request a meetingRun the numbers on your own site
Five models you can drive. Move the sliders, scrub the timeline, break the chain: the charts answer with the arithmetic the platform runs on real records.
What happens to your deviation backlog over a year?
Set your site's intake, team and cycle time. The model runs the year two hundred times and shows where the backlog lands with and without the platform.
Open after 12 months
25
109 fewer than without
Closed per month
33
26 without
Repeat deviations, year
40
61 without
Investigation cycle
23 d
35 d without
Each investigator carries about 6 open investigations at a time, so the team closes roughly 26 a month at a 35-day cycle. Arrivals vary month to month and 20% of closed deviations come back. Drag the sliders to your own site; the assessment measures the real figures.
The assessment runs these models on your real records.
Book an assessmentAgents that take on the routine work
Agentic automation handles the gathering, checking, drafting and chasing that fills a quality team's day. Agents work across your systems inside guardrails you define, so routine tasks get done faster, records stay inspection-ready, and your people spend their time on decisions.
Agentic architecture
IllustrativeOrchestrator agent: plans, routes and assembles
Intake agent
- Complaint inbox
- Call center
- Web forms
Investigation agent
- QMS
- Batch records
Trending agent
- LIMS
- MES
- QMS
Batch review agent
- eBR
- MES
Document agent
- DMS
- Regulatory files
Guardrails
- Least-privilege access per agent
- Draft-only writes
- Human approval gates
- Every tool call in the audit trail
- Models and prompts under change control
The day's scheduled tasks
Scheduled runs, shown complete
- 06:00:09 [orchestrator] plan: new events, records due this week, batches awaiting review, complaints
- 06:00:18 [intake] read 4 new complaints, 1 flagged as a possible adverse event
- 06:00:21 [investigation] queried QMS: 3 deviations due in 7 days, 1 overdue
- 06:00:30 [batch] checked the eBR queue: 2 batches ready, 1 with exceptions
- 06:00:39 [trending] reviewed EM and in-process results: no new trends
- 06:00:42 [orchestrator] drafted the huddle brief: 3 items need a decision
Ready for your review
- DEV-0142 impact assessment overdue: assign an owner
- Call center complaint flagged as a possible adverse event: route to pharmacovigilance
- Lot 24-121 batch record has 3 exceptions: assign a reviewer
Approve the brief: approved by the QA lead. Logged with every source and agent step.
Shown complete. Each task ends at a human approval.
Why an agentic architecture
Routine work runs on schedule
Huddle prep, overdue chasing and review packs are ready when your team starts the day.
One task, many systems
An orchestrator splits the work across agents that read QMS, LIMS, MES, ERP and documents in parallel.
Bounded by design
Each agent has a defined intended use, only the access it needs, and can draft but not approve.
Inspection-ready by default
Sources, tool calls and drafts are recorded, so an inspector can follow how every output was produced.
People stay accountable
Approvals, dispositions and reportability calls stay with qualified people. Agents bring them the work.
Which routine tasks would you hand to agents first?
Request a meetingOne deviation, start to close
Here is where AI does the groundwork and where your people make the call, at each stage of a deviation.
Deviation logged
AI drafts and flags
- Drafts the problem statement in IS / IS NOT form from the initial report
- Flags similar past events across batches, equipment and sites
Your qualified people decide
- Confirm the facts and the initial impact assessment
- Decide the classification and whether product is affected
audit trail · 14:02 draft generated · 14:10 routed to QA reviewer
Want to see how this would work with your systems and SOPs?
Request a meetingOne platform, every module on the same audited records
Licence the modules you need, or all of them, per user. Every module writes to the same hash-chained audit trail, signs with the same electronic signatures and links to every other record, so an OOS result, its investigation, the CAPA, the change control and the calibration of the instrument read as one story.
Quality events
- Complaint handlingTriage with the adverse-event check, evidence quoted from the complaint, and the decision signed.
- Investigations and CAPAsDeviation and OOS investigations with AI-drafted problem statements, hypotheses and root cause; CAPAs with owners, evidence and an effectiveness check.
- Batch record reviewExceptions found, assessed and dispositioned, with the recommendation signed by QA.
- Signal detectionControl charts with run rules on any parameter; each signal interpreted by the AI and dispositioned by QA.
- Backlog triageOpen deviations, CAPAs and change controls ranked by risk, with QA's priorities on record.
Documents and change
- Change controlAI impact and risk assessment, tasks, approvals to implement, effectiveness and closure.
- Document managementControlled documents with versions, AI review, approvals, training, effective dates and periodic review; every QMS document in one index.
- Regulatory submissionsChanges screened for regulatory impact; NDA and BLA sections drafted from templates.
- Risk assessmentDesign, process, equipment and CSV FMEA with RPN thresholds, mitigation actions and reassessment.
Laboratory, equipment and maintenance
- LIMSSpecifications, samples and results judged by the system, OOS handled under investigation, instruments and standards locked out when out of date.
- Electronic lab notebookEach 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.
- Calibration managementEvery instrument, tool and gauge: an approved requirement, calibrations with readings judged and reviewed by a second person, out-of-tolerance impact signed by QA.
- MESElectronic 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.
- GMP logbooksClean room, equipment and instrument logbooks kept as signed entries, with the periodic review the system checks first.
- PM LibraryA characterized, versioned particulate defect library for fill-finish: inspector qualification kits and AVI challenge sets that stay current.
- CMMSAssets with preventive plans and work orders verified for return to service; reliability, lifecycle and predicted failures from the history.
Validation and projects
Intelligence and automation
- Q IntelligenceAsk across every record, connect your systems, draft the next record for a person to review.
- Q Agent and agentsRoutine tasks worked by agents inside guardrails: flags, emails and schedules wait for a person's approval, and every record they draft stays in review.
- Q Dashboard and chartsThe quality system at a glance, and charts generated from your data, files or a live feed.
- Regulatory libraryFDA, ICH and EU GMP with page-level citations, inside every answer.
- AnalyticsTrends, capability and the metrics that show whether the system is in control.
- Security and Part 11Hash-chained audit trails, electronic signatures with password re-entry, access levels and a security log on every record.
- AI final reviewBefore any record is routed for approval, the AI reads it as the reviewers will and lists what to fix.
Licensed per module and per user, ordered by purchase order; no card, no self-serve plan.
Ask for a quoteWhat we implement
Five practice areas, delivered separately or as one program.
- 01
QMS digitization
Configured on the platform that fits your size and product type.
- Deviations
- CAPA
- Change control
- Complaints
- Document control
- Training
- Supplier quality
- APR/PQR
- 02
AI-assisted investigations
The AI drafts. Your investigators and QA decide.
- IS / IS NOT problem statements
- Fishbone
- 5-Whys
- CAPA effectiveness checks
- 03
Connected quality data
Your QMS linked to plant and lab systems for trending, recurrence detection and earlier signals.
- MES
- LIMS
- ERP
- Batch records
- 04
Validation of AI-enabled systems
Risk-based validation following GAMP 5 (Second Edition) and computer software assurance principles, documented for inspection.
- Intended use
- Risk assessment
- Test evidence
- CSA
- 05
Agentic workflow automation
Orchestrated agents that take on routine quality work across your systems: gathering, checking, drafting and chasing. Each one works inside defined guardrails and hands decisions to your people.
- Orchestrator and specialist agents
- Least-privilege access
- Draft-only writes
- Human approval gates
- Audit trail
Built for sites without a large quality IT team
Emerging and mid-size biotech and pharma
Moving from paper or hybrid systems to a validated, connected QMS ahead of clinical or commercial scale.
CDMOs and CMOs
Managing multiple client quality agreements, audits and tech transfers on one system.
503B outsourcing facilities
Meeting cGMP expectations with lean teams and high batch volume.
How an engagement runs
- 01
Assess
A QMS readiness assessment: processes, systems, data flows and backlog. We agree baseline metrics before anything changes.
- 02
Design
Target architecture, platform selection, and a defined intended use and risk level for every AI function.
- 03
Implement and validate
Configuration, integration, risk-based validation, SOP updates and training.
- 04
Monitor
Performance monitoring, change control for model updates, and periodic review against the baseline.
Most clients start with the assessment. Book one
AI in a decision-support role, by design
Every workflow we build keeps GxP decisions with qualified people and leaves a record an inspector can follow.
- Human review and approval for every GxP decision
- Audit trails and traceability for AI-generated content
- Data integrity to ALCOA+ expectations
- Change control for model and prompt updates
Frameworks we work to
- 21 CFR Part 11
- 21 CFR Parts 210/211
- 21 CFR Part 820 (QMSR)
- EU GMP Annex 11
- EU GMP Annex 22 (draft)
- ICH Q9(R1)
- ICH Q10
- GAMP 5 (2nd ed.)
- FDA CSA guidance
Annex 22 is a consultation draft at the time of writing. We design to its direction and update as final text is published.
What we baseline and track
We agree the measures in the assessment and report against them.
Hover or tap a measure to see it move from baseline to tracked. The figures are illustrative; yours are measured in the assessment.
Frequently asked questions
What does QLogix do?
QLogix provides AI transformation solutions for life sciences quality and operations: AI QMS software and QMS implementation for biotech, pharma, CDMOs and 503B facilities. It selects, configures, validates and connects the quality system, then adds AI workflows that draft, trend and flag while qualified people review and approve.
What is AI transformation in life sciences quality?
AI transformation in life sciences quality is moving deviations, CAPAs, change control, complaints, laboratory results, batch records and validation onto validated, connected systems where AI drafts, trends and flags from the evidence and qualified people decide. QLogix delivers it as a platform and as implementation services, built to 21 CFR Part 11, EU GMP Annex 11 and GAMP 5.
What is an AI QMS?
An AI QMS is a quality management system in which AI drafts records, investigations and assessments from the evidence on the record, quotes its sources and routes every decision to a qualified person, who approves with an electronic signature. The QLogix Agentic QMS records every AI contribution in a hash-chained audit trail.
Which modules does the QLogix platform include?
The QLogix platform covers eQMS with deviation and CAPA management, change control, document control, complaint handling, batch record review, quality risk management and FMEA, regulatory submissions, LIMS, an electronic lab notebook (ELN), MES with electronic batch records, GMP electronic logbooks, a particulate matter library for visual inspection, calibration management, CMMS, computer system validation and project management, all on one audited record store.
Who does QLogix work with?
Emerging and mid-size biotech and pharma companies moving from paper or hybrid systems to a validated, connected QMS; CDMOs and CMOs managing several client quality agreements on one system; and 503B outsourcing facilities meeting cGMP expectations with lean teams and high batch volume.
Does the AI make quality decisions?
No. AI drafts, summarizes, trends and flags. Review, approval and batch disposition stay with qualified personnel, and each AI contribution is recorded in the audit trail.
Do we have to replace our QMS?
Usually not. We start from what you have and recommend a change of platform only when the assessment shows the current one cannot meet the need.
How are AI functions validated?
With a risk-based approach: defined intended use, risk assessment, documented testing against acceptance criteria, and change control for any model update.
Which regulations and frameworks do you work to?
21 CFR Part 11, 21 CFR Parts 210 and 211, 21 CFR Part 820 (QMSR), EU GMP Annex 11, the draft EU GMP Annex 22, ICH Q9(R1), ICH Q10, GAMP 5 (Second Edition) and FDA's computer software assurance guidance.
Which platforms do you work with?
We are platform-agnostic and work across the major QMS platforms and their integrations with MES, LIMS and ERP.
How does an engagement start?
Most clients start with a QMS readiness assessment covering processes, systems, data flows and backlog. Baseline metrics such as deviation cycle time, backlog age, recurrence and right first time are agreed before anything changes.
Where do you work?
We are based in Newport Beach, CA and work on site across Southern California, with remote delivery elsewhere.
AI transformation for life sciences quality, topic by topic
QLogix delivers AI transformation solutions for life sciences: AI QMS software and QMS implementation for pharma, biotech, CDMOs and 503B facilities. One validated platform covers eQMS, deviation and CAPA management, change and document control, complaints, LIMS, the electronic lab notebook, electronic batch records, GMP logbooks, CMMS, calibration and computer system validation, built to 21 CFR Part 11 and EU GMP Annex 11.
Services
- QMS digitization
QMS digitization · QMS implementation · paper to eQMS · eQMS selection · QMS configuration · QMS validation · QMS migration
- AI-assisted investigations
AI-assisted investigations · AI root cause analysis · deviation investigation · CAPA effectiveness · 5 Whys and fishbone analysis · AI for deviations
- Connected quality data
connected quality data · QMS integration · LIMS, MES and ERP integration · quality data integration · quality metrics · data integrity
- Validation of AI-enabled systems
validation of AI-enabled systems · AI validation · AI model validation for pharma · GAMP 5 for AI · computer software assurance · EU GMP Annex 22 readiness
- Agentic workflow automation
agentic workflow automation · AI agents for quality · agentic AI in GxP · quality workflow automation · human-in-the-loop AI
Quality events
- Investigations and CAPAs
CAPA software · deviation management software · root cause analysis software · OOS investigation software · CAPA effectiveness check · 5 Whys and fishbone analysis · corrective and preventive action system · GMP deviation investigation
- Complaint handling
complaint handling software · complaint management system · pharmaceutical complaint handling · medical device complaint handling · 21 CFR 211.198 complaint files · 21 CFR 820.198 complaint handling · adverse event triage · MDR and field alert reportability assessment
- Batch record review
batch record review software · review by exception · batch record review by exception · executed batch record review · batch release review · QA batch disposition · electronic batch record review · GMP batch record review
Documents, change and risk
- Change control
change control software · GMP change control · change management for pharma · change impact assessment · regulatory impact of changes · change control effectiveness check · ICH Q9 change risk assessment · pharmaceutical change control system
- Document control
document control software · GMP document management system · SOP management software · controlled documents · document periodic review · read and understood training · pharmaceutical document control · electronic document management for life sciences
- Risk assessment
quality risk management software · FMEA software · ICH Q9(R1) · pFMEA · dFMEA · equipment FMEA · CSV FMEA · risk priority number · risk assessment for pharma · mitigation tracking
- Regulatory submissions
regulatory submissions software · post-approval changes · regulatory impact assessment · CMC changes · eCTD · NDA dossier drafting · BLA dossier drafting · CBE-30 and prior approval supplement · EU variations
Laboratory, manufacturing and equipment
- LIMS
LIMS for pharma · LIMS software for QC laboratories · pharmaceutical LIMS · OOS management software · out-of-specification investigation · certificate of analysis software · reference standard management · instrument calibration lockout · GMP laboratory data integrity
- Electronic lab notebook
electronic lab notebook · ELN for QC laboratories · GMP electronic lab notebook · analytical assay documentation · ELN LIMS integration · laboratory data integrity · QC lab software
- MES (electronic batch records)
MES for pharma · electronic batch records · EBR software · eBR system · master batch record · review by exception · manufacturing execution system · MES ERP integration · batch release
- GMP logbooks
electronic logbooks for GMP · GMP electronic logbook · equipment logbook software · cleanroom cleaning log · instrument logbook · logbook periodic review · ALCOA+ data integrity · eLogbook
- PM Library
particulate matter library · visual inspection qualification · AVI challenge set · defect library for fill-finish · inspector requalification · visible particulates in injections · USP 790 and 1790 · Annex 1 visual inspection · FTIR particle identification
- Calibration management
calibration management software · GMP calibration · instrument calibration tracking · as-found and as-left results · out-of-tolerance impact assessment · calibration scheduling · metrology software
- CMMS
CMMS for GMP · GMP maintenance software · computerized maintenance management system · preventive maintenance software · work order management · asset management for pharma · predictive maintenance · MTBF and MTTR · equipment reliability
Validation and projects
- Validation
computer system validation software · CSV and CSA · computer software assurance · GAMP 5 validation · paperless validation · validation lifecycle management · IQ OQ PQ protocols · electronic test execution · traceability matrix
- Project management
GxP project management · validation project management · critical path scheduling · earned value management · validation program tracking · project resource planning
AI for quality
- Agentic QMS
eQMS software · QMS software for life sciences · AI QMS · agentic QMS · electronic quality management system · pharma QMS software · quality management software for biotech · medical device QMS software · cloud QMS
- Q Intelligence, Q Agent and agents
AI for pharmaceutical quality · AI in GxP · generative AI for QMS · AI agents for quality assurance · AI quality assistant · AI with human approval · EU GMP Annex 22 · FDA AI credibility framework
From the blog: AI and quality in life sciences
- Manufacturing science ·
Signal detection in GMP: how control charts with run rules catch a shift or a drift before it becomes a deviation
A result inside specification can still be the first point of a shift that ends in an out-of-specification batch three lots later. Control charts with alert limits at two sigma, action limits at three and Nelson's run rules see the shift while every result still passes. When the chart, the AI's reading of each signal and QA's disposition sit on one audited record, trending stops being an annual review exercise and becomes continued process verification.
Read the article - AI in quality ·
Backlog triage: ranking open deviations, CAPAs and change controls by risk instead of by age
Most quality backlogs are worked in the order they arrived, which means the deviation on a sterile batch waits behind a labelling query from March. Triage by risk ranks every open item on patient and product impact, regulatory exposure, recurrence, due dates and age, says why in one line each, and puts QA's decision on each priority on record. The queue is then worked in the order that matters, and the order is defensible.
Read the article - AI in quality ·
Predictive maintenance in GMP: how CMMS, calibration and reliability data decide when equipment is serviced, calibrated and replaced
A preventive interval copied from a manual is a guess. The work orders, downtime and calibration results a site already records contain the answer: mean time between failures, availability, whether failures are rising with age, and the interval that catches most of them before they happen. When the CMMS, the calibration module and the quality system share one record graph, the model reads itself, the engineer confirms, and the change goes through change control.
Read the article
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