Controlled Templates & Document Packs
Upload approved templates, create controlled records and assemble qualification or quality packs around the intended workflow.
GxP qualification & controlled quality workflows
Bring qualification, quality actions and approval into one controlled GxP workflow.
Nvirosense™ brings controlled templates, qualification records, CAPA, change control, electronic approval and linked monitoring evidence into one reviewable workspace for regulated operations.
Controlled Templates
Qualification
CAPA
Change Control
Electronic Approval
Audit History
Controlled quality delivery
Keep every controlled record, approval and quality action connected.
AutoQMS™ gives quality and validation teams a structured workspace for controlled documents, assigned actions, evidence capture and review. Monitoring data, calibration records and qualification evidence remain linked to the work that depends on them, while customer quality governance remains in place.
Assigned Actions & Evidence
Give owners clear actions, collect supporting evidence and see completeness before the record moves to review.
Electronic Approval & Audit History
Support controlled review with role-based access, electronic signature or token approval, and a reviewable history of actions and changes.
Illustrative product proof
The AutoQMS™ Workspace
Show a representative qualification or quality record with document status, assigned actions, linked assets and evidence, approval stage, CAPA or change references and audit history. Use clearly marked demonstration data only.
Representative AutoQMS™ Qualification Record
Approved field set for controlled workflow context
- Record Status
- Available in the defined record
- Owner
- Available in the defined record
- Controlled Template
- Available in the defined record
- Linked Evidence
- Available in the defined record
- Approval Stage
- Available in the defined record
- CAPA or Change Reference
- Available in the defined record
- Audit History
- Available in the defined record
Core AutoQMS™ capabilities
Qualification Workflows
Structure URS, risk assessment, DQ, IQ, OQ, PQ and mapping activities with the relevant documents, actions, evidence and review points.
Controlled Electronic Records
Support role-based access, electronic approval, signature or token controls and a traceable record history within the defined workflow.
Calibration-Linked Evidence
Connect the relevant certificate, validity state and calibration history to the asset, record or qualification pack that depends on it.
CAPA & Change Control
Record quality actions and controlled changes with accountable ownership, required evidence, approval steps and a traceable history.
Qualification, delivered with control
Move from requirement to approved qualification evidence with a controlled pathway.
Nvirosense™ combines validation and mapping expertise with a controlled digital workflow. Qualification templates, assigned actions, supporting evidence and approval stages can remain connected from initial requirements through to the completed pack. Customers retain responsibility for final quality decisions and regulated release.
A site survey can establish user requirements, logger placement, communication coverage and thermal-risk areas before the monitoring plan and qualification workflow are executed.
URS
Capture requirements in a controlled template, assign contributors and move the record through defined review and approval steps.
Risk Assessment
Record critical risks, decision criteria and mitigations before deployment, with the evidence required for review.
Design Qualification
Connect approved requirements to the deployment design, device layout, reporting scope and implementation evidence.
Implementation & Verification
Track installation actions, configuration checks and as-built evidence against the approved design.
IQ / OQ
Execute required installation and operational checks, link evidence to the protocol and progress the pack for controlled review.
PQ + Mapping Evidence
Bring performance evidence, mapping outputs, conclusions and required approvals into the qualification record for review.
Controlled workflow lifecycle
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01
Controlled Template
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02
Execute & Collect Evidence
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03
Review
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04
Electronic Approval
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05
Completed Record
URS · Risk Assessment · DQ · IQ · OQ · PQ · Mapping Evidence
Keep control after go-live
Keep quality actions, controlled changes and operational evidence moving after qualification.
When an exception, corrective action or planned change needs attention, AutoQMS™ keeps the responsible people, controlled record, linked evidence and approval history together. Monitoring and calibration context can be connected where it informs the quality decision.
CAPA
Create, assign, review and close corrective or preventive actions with the evidence and approvals required by the defined process.
Change Control
Assess and document controlled changes to the monitored environment, workflow or configuration before the approved change is implemented.
Electronic Approval & Audit History
Keep authorised review events, signature or token interactions, timestamps and record history visible alongside the controlled work.
The right workflow for the right decision
Connect AutoQMS™ to the operational and evidence layers around it.
Use Pharmaceutical Monitoring for environmental conditions and excursions. Use Compliance & Traceability for cross-industry record continuity, standards alignment and controlled outputs. Use AutoQMS™ to organise the controlled quality and qualification work between them.
How IoT Is Reshaping Quality Control in Pharma
Bring monitored conditions and traceable events into quality review workflows.
Read insightReal-Time Monitoring for Pharmaceutical Quality and Safety
Use continuous evidence to support product-quality and patient-safety decisions.
Read insightEnvironmental Monitoring for Cryostorage Applications
Support critical repositories with independent records, alarms and review context.
Read insightPlan the controlled workflow
Start with the records, approvals and evidence your process needs.
Define the qualification scope, controlled templates, responsible roles, linked monitoring or calibration evidence and approval path before the workflow is configured around your operation.