Quality-system expectations continue to evolve while device teams must connect design, manufacturing and post-market evidence across long product lifecycles. Fragmented context makes every review and investigation harder than it should be.
Requirements, reviews, tests, risk evidence and rationale remain separated across tools and teams.
Teams repeatedly reconstruct which evidence supports a requirement, change, investigation or decision.
Complaints, service events and manufacturing issues do not always reach future design decisions quickly.
Specifications, quality history, contracts, risk and product dependencies are reviewed in separate workflows.
Critical design, quality and regulatory reasoning can remain concentrated in experienced individuals.
Facthory relates engineering evidence, quality history, operations and field feedback so people and agents can reason across the full device lifecycle.
Connect design inputs, user needs, constraints, acceptance criteria and approved interpretations.
Connect alternatives, design rationale, identified risks, controls and related technical evidence.
Connect protocols, test evidence, results, acceptance criteria, deviations and expert review.
Connect process evidence, nonconformances, investigations, procedures, maintenance and approved corrective learning.
Connect complaints, service history, field observations, recurring symptoms and reviewed outcomes.
Preserve review, assumptions, authority, evidence and approved rationale as reusable organizational memory.
Focus on workflows where engineering speed, product quality and lifecycle learning depend on shared, reviewable context.
Connect requirements, design evidence, trade-offs and field feedback around product-development decisions.
Investigate nonconformances, recurring failures and corrective learning across manufacturing and product evidence.
Keep validated procedures governed and connected to the operational evidence they control.
Investigate quality, manufacturing, complaint and service patterns across governed enterprise data.
Connect supplier quality, contracts, risk and operational dependencies around sourcing decisions.
Identify critical technical and quality knowledge concentrated in people or fragmented evidence.
Design evidence should remain connected as the product moves from definition through verification, transfer and field learning.
Connect intended use, user needs, requirements, standards and technical constraints.
User needs
Requirements
Standards
Constraints
Facthory supports engineering investigations by connecting internal evidence, technical research and lifecycle feedback. It does not replace engineering judgment, formal design controls or required verification and validation processes.
Connect user needs, design inputs, constraints and acceptance criteria before comparing technical options.
Compare concepts against performance, usability, cost, manufacturability and other defined engineering criteria.
Keep identified risks, controls, related evidence and review context connected to design decisions.
Relate test protocols, results, deviations and conclusions to the requirements they address.
Investigate standards, literature, patents, prior art and internal technical evidence around engineering questions.
Preserve reviewed rationale, rejected alternatives, assumptions and downstream feedback for future projects.
A connected record should show not only where evidence lives, but what it supports, what changed and who reviewed the conclusion.
Connect requirements with supporting tests, technical records, risks, reviews and downstream observations.
Surface affected requirements, evidence, suppliers, procedures and prior decisions around a proposed change.
Preserve evidence, assumptions, reviewers and approved conclusions behind consequential technical decisions.
Facthory can connect nonconformances, complaints, manufacturing evidence, service history and approved corrective actions around investigations. It does not replace the quality system or make autonomous reportability, product-release or patient-safety decisions.
Assemble product, process, supplier, test and manufacturing evidence around recurring quality issues.
Keep investigation evidence, approved actions, owners, validation and recurrence connected around corrective work.
Connect symptoms, device history, service actions, similar cases and expert assessment for investigation.
Surface patterns across products, lots, suppliers, sites and field evidence for accountable expert review.
Facthory helps device organizations move faster without discarding the traceability, review and accountability required for high-consequence technical work.
Reduce repeated evidence reconstruction across engineering investigation and design review.
Reuse validated investigation and corrective learning across products, processes and sites.
Keep findings and recommendations connected to the evidence and review behind them.
Preserve technical and quality rationale across long product lifecycles and team changes.
Facthory can support regulated workflows with controlled context, provenance and human review. Validation and governance requirements depend on how each organization intends to use the system.
Establish purpose, users, source systems and the decisions the AI may support.
Purpose
Users
Sources
Boundaries
PLM, eQMS, ERP, manufacturing, test, service and document systems remain authoritative. Facthory connects relevant evidence through governed enterprise integration patterns where interfaces and permissions allow.
Connect product structures, requirements, changes and engineering records through available enterprise interfaces.
Connect nonconformances, CAPA, audits, complaints and controlled quality evidence where authorized.
Connect materials, lots, production, suppliers, maintenance and operational history relevant to investigations.
Connect protocols, measurements, test outputs and supporting analytical data for evidence-based review.
Connect approved field, service and complaint records with product and manufacturing context.
Connect controlled documents, standards, guidance and approved regulatory interpretations with source permissions preserved.
Engineering records, quality evidence, complaint data and proprietary device knowledge can be highly sensitive. Facthory supports deployment choices for different enterprise security and data-control requirements.
Use a managed enterprise environment with governed identity, permissions and operational context.
Deploy the platform in a customer-controlled cloud environment.
Operate within a private environment aligned to internal security and data requirements.
Run Facthory locally where infrastructure, data or model control requires it.
Choose one repeated workflow where qualified teams already spend measurable effort reconstructing lifecycle evidence before they can make progress.
Start with a recurring engineering review requiring requirements, risk, verification, technical research, change history and expert rationale to be reconstructed.
Start with a repeated complaint pattern requiring device, lot, service, manufacturing, supplier and prior-investigation evidence to be connected.
How Facthory turns probabilistic agent reasoning into governed industrial execution through deterministic controls, durable workflows, evidence, human authority and verification.
Why quality, maintenance and engineering problems need shared evidence, persistent context and multiplayer AI workflows rather than isolated copilots.
How Facthory turns reviewed work into versioned, scoped agent skills using tenant isolation, held-out evaluation, human publication, canary releases, rollback and independent runtime authorization.
Capabilities can include:
Findings can be linked to the supporting records, responsible teams, affected procedures, and recommended actions.
Read about Manufacturing Quality and Reliability Intelligence.
Depending on your environment and deployment, sources may include:
Connections can be established through supported integrations, APIs, secure file ingestion, or purpose-built connectors.
Explore Systems and Data Connectivity or contact us about an integration.
Experts can inspect evidence, correct assumptions, redirect agents and approve consequential findings, procedures or actions. Facthory preserves those reviews as part of the operational record.
Storage location, retention, processing region, model access, and backup arrangements depend on the agreed deployment architecture. Enterprise customers can define requirements relating to:
These requirements are reviewed during solution design and documented as part of the deployment.
For a detailed assessment, contact our enterprise team.
Good initial use cases often have:
Facthory can then establish the necessary context, integrations, governance, and agent capabilities around that use case before expanding into a broader operational intelligence program.
Explore our solutions, book a demonstration, or contact sales.
Connect design, verification, quality, manufacturing and field evidence so each reviewed decision strengthens the next product change, investigation and development cycle.
