Improve quality workflows without giving AI final authority.
Verixa connects Quality Events and Controlled Documents & Change Control on one platform. Bring workflow, source context, AI assistance, human review, and authorized decisions into a traceable process.
Start with one defined workflow, clear responsibilities, and measurable success criteria.
One platform. Two focused applications.
Verixa is a governed-AI quality workflow platform for regulated life sciences. Begin with Quality Events or Controlled Documents & Change Control, then expand through supported platform capabilities.
Verixa is not positioned as a full-suite eQMS replacement for every quality-system function. It can work alongside an established QMS or eQMS, or be evaluated as the authoritative record for one defined workflow.
Bring evidence, review, and decisions into one workflow.
Critical quality work often spans approved systems, documents, email, spreadsheets, and meetings. That fragmentation slows review and makes decisions harder to reconstruct.
Keep source evidence and investigation context connected.
Retain root-cause and CAPA rationale through review.
Link document changes, training impact, and change control.
Use AI within the workflow, with clear sources, roles, and review gates.
Start with a high-value quality workflow.
Verixa Quality Events
Connect the quality-event evidence chain from intake through closure.
Workflow may include
- Intake, triage, risk, and impact assessment
- Investigation planning and execution
- Root-cause evaluation and decision support
- CAPA planning, execution, and evidence
- Effectiveness evaluation
- Closure, controlled reopening, and related change control
Full lifecycle, as currently published:
- Deviation intake and triage
- Risk and impact assessment
- Investigation planning and execution
- Root-cause analysis
- CAPA initiation and planning
- CAPA execution and evidence
- Effectiveness evaluation
- Closure, rejection, or controlled reopening
- Related change-control initiation
- Reviewable evidence preparation
Verixa Controlled Documents & Change Control
Connect controlled authoring with the revision and change lifecycle.
Workflow may include
- Controlled authoring and collaborative review
- Comment resolution and quality approval
- Issuance, effective-date control, and periodic review
- Reason-for-change capture and linked change control
- Training-impact identification and handoff
- Supersession, obsolescence, version, lineage, and approval traceability
Full lifecycle, as currently published:
- SOP and controlled-document authoring
- Structured collaborative review
- Comment resolution and revision
- Quality review and approval
- Issuance or effective-date control
- Periodic review
- Reason-for-change capture
- Linked change control
- Training-impact identification and handoff
- Supersession and obsolescence
- Version, lineage, and approval traceability
Governance built into the workflow.
Configurable workflows
Configure supported templates, stages, rules, roles, escalations, and review gates.
Human decision authority
Keep approvals, signatures, dispositions, effectiveness conclusions, and closures with authorized people.
Traceable AI assistance
Where supported, connect source context, AI contributions, human changes, and resulting actions.
Controlled AI change
Manage approved models, providers, instructions, knowledge sources, configurations, and relevant changes.
Reusable platform services
Share identity, access, workflow, review, traceability, integration, and change-history services across applications.
Configuration and expansion use supported product capabilities. Any broader extension requires separate agreement on security, support, lifecycle controls, and responsibilities.
Outside the platform boundary: unapproved external AI models or providers, customer-created agents acting outside approved workflows, and any change that bypasses review, approval, signature, traceability, or change-control requirements.
AI assists. Authorized people decide.
AI has a specific, reviewable role within each configured workflow.
AI may assist with
- Drafting or summarizing content
- Retrieving approved source material
- Identifying possible gaps or inconsistencies
- Comparing records or evidence
- Proposing classifications or next steps for human review
AI does not independently
- Approve or electronically sign a controlled record
- Make a final quality or product disposition
- Release a batch
- Select or approve a root cause, CAPA plan, or effectiveness conclusion
- Make a document effective or close a quality event
- Override an authorized person's responsibility
Authorized users review, accept, modify, or reject AI contributions according to their assigned roles.
Illustrative product interface using demonstration data.
Choose how Verixa fits your quality landscape.
Alongside an established system
Your existing system remains authoritative for its approved records. Verixa supports the selected workflow with evidence assembly, traceability, AI assistance, and human review. Interfaces, mappings, reconciliation, and responsibilities are defined before use.
As the authoritative record for one workflow
Where no suitable system exists, Verixa may be evaluated as the authoritative record for a defined workflow. The customer must approve the intended use, records, configuration, roles, procedures, training, assurance approach, and change responsibilities before operational use.
An alongside deployment does not become authoritative without an approved change in scope.
Define ownership before implementation.
Verixa provides available product and release information for the agreed scope. The customer remains responsible for approving its intended use and configured implementation.
| Area | Verixa responsibility | Customer responsibility |
|---|---|---|
| Intended use and records | Provide scoping guidance and document supported behavior | Define, assess, and approve the intended use and authoritative records |
| Product and releases | Control the product lifecycle and provide available release information | Assess supplier information against the planned use |
| Configuration, roles, and access | Provide supported configuration and permission capabilities | Approve configuration, assign access, and review it periodically |
| Procedures, training, and AI oversight | Provide available product-use and AI-governance information | Establish procedures, qualify users, and approve human oversight |
| Validation or assurance | Provide available information for the agreed release and scope | Determine, execute, and approve the validation or assurance approach |
| Integration, migration, and change | Provide supported tooling and applicable change information | Approve mappings, reconciliation, acceptance, controls, and change actions |
Verixa responsibility
Provide scoping guidance and document supported behavior
Customer responsibility
Define, assess, and approve the intended use and authoritative records
Verixa responsibility
Control the product lifecycle and provide available release information
Customer responsibility
Assess supplier information against the planned use
Verixa responsibility
Provide supported configuration and permission capabilities
Customer responsibility
Approve configuration, assign access, and review it periodically
Verixa responsibility
Provide available product-use and AI-governance information
Customer responsibility
Establish procedures, qualify users, and approve human oversight
Verixa responsibility
Provide available information for the agreed release and scope
Customer responsibility
Determine, execute, and approve the validation or assurance approach
Verixa responsibility
Provide supported tooling and applicable change information
Customer responsibility
Approve mappings, reconciliation, acceptance, controls, and change actions
Specific support deliverables are agreed during scoping. Verixa does not certify a customer's compliance, validation status, or inspection readiness.
Built for regulated quality teams solving a defined workflow.
Verixa may be a good fit when you
- Need to improve a Quality Events or Controlled Documents workflow.
- Want AI assistance while keeping final authority with people.
- Need clearer evidence, review, decision, and change traceability.
- Can define the workflow, owner, authoritative records, and success criteria.
Common stakeholders include Quality, Quality Systems, QA Operations, Digital Quality, assurance, regulatory, IT, and security leaders.
Verixa may not be the right fit when you
- Need an unrestricted build-anything platform.
- Want AI to make autonomous final quality decisions.
- Cannot define the workflow, ownership, records, or success criteria.
- Need a capability Verixa does not currently support.
- Already run the selected workflow effectively and would gain no meaningful operating value.
Scope one workflow before deciding how to proceed.
In a focused working session, we map:
- The workflow and authoritative records
- Evidence gaps and difficult handoffs
- Human decisions and AI boundaries
- Configuration, integration, assurance, and responsibilities
- Measurable success and exit criteria
Bring to the session
- One de-identified workflow example
- The roles and systems involved
- The hardest evidence handoff or review point
Use only de-identified, process-level information. Do not submit personal, patient, batch, product-confidential, client-confidential, or controlled-record content.
A focused conversation to assess fit, scope, responsibilities, and next steps. The call does not provide a compliance or validation conclusion.
Frequently asked questions
Verixa supports defined electronic quality workflows but is not positioned as a full-suite eQMS replacement. It is a governed-AI quality workflow platform with focused applications for Quality Events and Controlled Documents & Change Control.
Start with one workflow.
Map the records, evidence gaps, human decisions, AI boundaries, responsibilities, and success criteria with Verixa.