Close deviations and CAPAs faster, without loosening control.
QLogix selects, configures, validates and connects quality management systems for biotech, pharma, CDMOs and 503B facilities. Then we 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 meetingAgents 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
Run a daily task
- waiting to start
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 meetingWhat 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.
Cycle time
Deviation open to close
Backlog age
Open CAPAs and change controls
Recurrence
Repeat deviations by root cause
Right first time
Batch records and investigations
Frequently asked questions
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