StromaOS connects deviations, investigations, CAPA, complaints, process knowledge, suppliers, stability, specifications, change control, regulatory impact, and lifecycle quality operations in one governed execution environment.
CMC and quality decisions can affect product, process, batch, method, site, supplier, specification, validation, stability, filing, market, supply, and patient risk. The relevant evidence is usually distributed across validated systems, documents, spreadsheets, meetings, and specialist teams.
Quality events, manufacturing data, laboratory records, equipment history, materials, suppliers, complaints, stability, prior CAPA, and change records are rarely reviewed as one connected evidence set.
Similar events recur because prior hypotheses, eliminated causes, supporting evidence, remediation, effectiveness, and decision rationale are trapped in static records.
A proposed process, method, specification, supplier, equipment, or site change can affect validation, stability, supply, filings, commitments, and markets in different ways.
AI can retrieve, compare, cluster, summarize, and draft, but it cannot be allowed to determine root cause, approve CAPA, release product, authorize change, or close an event without accountable quality authority.
StromaOS coordinates quality evidence, investigation, trends, risk, root-cause hypotheses, CAPA, change control, regulatory impact, validation, accountable review, and closure in one execution model.
Deviation, OOS/OOT, complaint, trend, supplier issue, process signal, change, or regulatory commitment.
Batches, methods, equipment, materials, sites, suppliers, process history, prior events, CAPA, stability, and filings.
Hypotheses, evidence, eliminated causes, recurrence, impact, risk, product, patient, supply, and market context.
Root cause, disposition, CAPA, change, validation, release, escalation, filing, and approval decisions.
Containment, correction, prevention, training, implementation, verification, monitoring, and regulatory action.
Effectiveness, residual risk, evidence, decisions, approvals, closure, recurrence, and reusable quality memory.
StromaOS connects a proposed process, method, specification, supplier, site, equipment, material, packaging, or analytical change to affected products, batches, validation, stability, supply, markets, filings, commitments, risks, actions, and decision authority.
Change becomes a governed multi-functional execution record rather than a routing form.
Model a change-control workflow
Change impact, closure and filing consequence stay connected. The chain from a deviation to its regulatory impact is traversable rather than reconstructed under inspection.
StromaOS separates retrieval, trend detection, hypothesis generation, evidence synthesis, recommendation, root-cause decision, disposition, CAPA approval, change approval, release, filing, implementation, and closure.
Explore the Governance SpineAuthoritative quality, laboratory, manufacturing, validation, supplier, and regulatory records remain in their validated systems while StromaOS governs cross-system execution.
Hypotheses, evidence, eliminated causes, related events, risk, impact, required methods, reviewers, and decision authority are explicit and versioned.
AI may retrieve, compare, detect patterns, and draft without receiving authority to determine root cause, approve disposition, authorize change, release product, or close an event.
Progression and closure depend on required evidence, validation, review, approval, implementation verification, residual risk, and effectiveness criteria.
Inputs, methods, models, prompts, versions, hypotheses, decisions, approvals, CAPA, changes, filings, implementation, effectiveness, and closure remain reconstructable.
Connect the quality sources and validated systems already in use. Define the evidence standard, authority, quality gates, impact dimensions, regulatory obligations, and closure criteria. Then run the work as one governed quality operation.