Medical devices + IVDs
Current focusComplaints, vigilance assessments, CAPA, supplier quality, PMS, controlled evidence, and regulatory change across the US, EU, and MDSAP five.
View solution Investigation Intelligence · Therapeutic biotech previewDetect quality risk earlier.
Detect quality risk earlier.
Investigate with evidence.
Stay inspection-ready.
QMS Studio connects quality signals, controlled evidence, human decisions, and regulatory change across medical devices, IVDs, and an honestly scoped therapeutic-biotech expansion.
Interactive demonstration · Synthetic records · Human approval required
Medical devices + IVDsCurrent product focusTherapeutic biotechExpansion previewHuman-governed AINo autonomous closureRegulatory horizonBinding vs watch-only
Investigation IntelligenceThe system finds the pattern.
The system finds the pattern.
Your quality team decides.
Bring complaints, deviations, OOS/OOT results, lots, suppliers, equipment, methods, analysts, controlled procedures, and prior CAPAs into one cited evidence trail.
CMP-2026-0142 · Synthetic record
AI draft · cited · human verification requiredUnexpected false-negative trend across three sites
Ready to scan permission-filtered synthetic records
Evidence before answers.
The analysis stays empty until governed retrieval runs. No uncited conclusion is filled in.
AI assembles evidence and drafts hypotheses. It cannot determine root cause, reportability, batch disposition, CAPA approval, effectiveness, or closure.
AskInvestigateProveHuman decision
Purpose-built operating models
Start with the quality system you actually operate.
One governed evidence layer, with controls and terminology that stay honest about each domain’s maturity.
Therapeutic biotech
Expansion previewDeviations, OOS/OOT, batch-impact assessment, QA disposition, validation, quality agreements, lot genealogy, and PQR/APQR requirements.
View solutionRegulated laboratories
Workflow blueprintQC/PT failure, instrument, reagent, analyst evidence, and controlled corrective action. CLIA operations remain a separate compliance pack.
View solutionCRO + CDMO
Workflow blueprintMulti-client quality events, affected sponsors, quality-agreement obligations, delegated actions, and outsourced-manufacturing oversight.
View solutionTherapeutic biotech · expansion preview
From development signal to controlled QA disposition.
Representative requirements and UI are included; production configuration, validation, integration, and qualified regulatory assessment remain required.
- 01Development
- 02Tech transfer
- 03Manufacturing
- 04Quality-unit disposition
- 05Continual improvement
A connected quality model
Product / programDrug substanceDrug product / biologicSiteBatch / lotMaterialMethod / specificationEquipmentContractorRegulatory commitment
Representative expansion basis
21 CFR Parts 210/211 and applicable Parts 600–680 · 21 CFR Part 11 · EU GMP Parts I/II and selected annexes · ICH Q7–Q10/Q12.
Mapped—not certified. This is not a blanket pharmaceutical-GMP coverage claim.
Regulatory horizon
Upcoming changes, translated into quality work.
Every item carries an exact date or watch-only status, an applicability boundary, an evidence gap, and a human decision gate.
Devices + IVDsBinding and applicability-assessment dates
EUDAMED legacy-device registration
Inventory, identifier, actor, and evidence-completeness work for applicable legacy devices.
EU Product Liability Directive transposition
Software-product evidence preservation, disclosure readiness, and defensible decision records.
EU AI Act high-risk applicability assessment
Provider/deployer role, intended use, Annex I product link, model inventory, and human oversight.
Therapeutic biotechExpansion horizon
Revised EU GMP Annex 19 applies
Reference and retention sample inventories, quantities, storage, test capability, and written agreements.
EU SoHO Regulation generally applies
Applicability branching for upstream donor, testing, collection, release, and relevant ATMP supply chains.
EU GMP Chapter 4 / Annex 11 / Annex 22 drafts
Scenario planning for data integrity, cloud/supplier controls, computerized systems, and AI governance.
Official sources: EUDAMED rollout · Product Liability Directive · AI Omnibus · EU GMP Annex 19 · EU SoHO Regulation · EU GMP draft consultation.
Honest coverage
Know exactly what is represented.
“Supported” always means supported in the synthetic demonstration—not validated for a customer’s intended use.
Medical devices + IVDsCurrent focus
Requirements and demonstration workflows represented across US, EU, and MDSAP five.
Therapeutic biotechExpansion preview
Representative US/EU GMP requirements and UI; production configuration and validation remain required.
Regulated labs + CRO/CDMOWorkflow blueprint
Intended workflow only; complete regulatory logic is not claimed.
General pharma, GCP, pharmacovigilanceNot covered
Separate validated platforms and compliance packs are required.
Trust & validation roadmap
Enterprise trust, without vague compliance claims.
The demo shows the control model. The Trust Center separates demonstrated patterns, production requirements, and independent assurance.
Human-governed AIDemonstrated in synthetic workflowsDemonstrated
AI provenance + evidence linksVisible source versions and decision stateDemonstrated
Part 11 / GxP control designDeployment is not validatedSpecified
SOC 2 Type II / ISO 27001No report or certification claimedPlanned
Public demo dataNo confidential data, personal data, PHI, or regulated recordsSynthetic only
See the evidence pathBring one quality workflow.
Bring one quality workflow.
See how it becomes governed evidence.
Map a complaint, deviation, OOS, supplier issue, or regulatory change against QMS Studio.