From Record to Review

Keep monitored events traceable from source to report.

Nvirosense™ connects device identity, timestamps, readings, calibration context, acknowledgements, audit history and controlled outputs so operational and quality teams can review how each record was created, handled and reported.

Selected standards and alignment pathways

Review the supported evidence pathway for each framework.

Quality and operations reviewer examining traceable device records, calibration status and audit history.

Responsibility Stays Clear

Support controlled review without replacing formal approval.

Nvirosense™ provides traceable records, analytics, alerts, reports and workflow evidence to support informed review. Authorised customer personnel remain responsible for regulatory release, qualification approval, certification and QMS sign-off.

Traceable Event History

Connect events, user actions, changes, acknowledgements and report outputs into a history that authorised reviewers can follow.

Measurement Context

Link device identity and calibration status to certificates, reference information and validity dates.

Controlled Outputs

Prepare PDF, XLSX and scheduled reports that remain connected to the source records used for review.

Live Compliance Workspace

Review source, status and history without losing context.

Bring device identity, recorded values, configured limits, calibration status, acknowledgements, user history and report access into one reviewable workspace.

Nvirosense™ representative workspace

Source, event, calibration and report context

Demonstration data

Review records

Source + device identity

Environmental monitor

DEMO-ENV-014 · Process Area A

30 Jul 2026 · 14:32 SAST

Last seen 2 minutes ago

Configured limits + status

27.4 °C

Configured range 18–26 °C

Review required

Calibration status + validity

Status
Current
Certificate
DEMO-CAL-014
Valid / due
15 Jan 2027

Acknowledgements + user history

Acknowledged for review

Demo Reviewer · timestamp retained

Report access

PDF availableXLSX availableScheduled output current

Audit history

  1. Event recorded
  2. Notification routed
  3. Acknowledged for review

The Evidence Chain

Preserve context from the first reading to the final report.

Keep a clear record of who or what created each event, when it occurred, how its context was checked, what action followed and where the evidence was retained.

  1. Record the Source

    Record the reading or event with its device, source, location and timestamp context.

  2. Confirm the Context

    Check reading quality, device state, configured limits and linked calibration context where available.

  3. Maintain Continuity

    Use configured transport, local buffering and synchronisation controls to maintain continuity through connectivity interruptions.

  4. Route Action

    Move configured events into alerts, notifications, acknowledgements and assigned review actions.

  5. Preserve the Evidence

    Retain dashboards, reports, AutoQMS™ records and event history with the context required for controlled review.

Compliance in Practice

Apply one evidence chain across different regulated workflows.

The structure of the record remains consistent while the operational context, review process and applicable requirements change.

Perishable export condition records and controlled reporting prepared for operational review.

PPECB Export Reporting

Bring device groups, condition history and controlled reporting into the evidence used for perishable export review, without replacing PPECB or customer release controls.

Explore Logistics / Export

Electronic record · demonstration

Under review
Authenticated user
Demo Reviewer
Record ID
DEMO-EVR-1042
Timestamped action
Acknowledged · 14:41 SAST
Authorisation state
Review permission active
E-signature evidence
Available where configured

21 CFR Part 11 Records

Support electronic-record controls with authenticated access, audit history, authorisation and e-signature evidence where configured. Part 11 applicability and validation remain system- and use-specific.

Explore GxP & AutoQMS™
Device calibration record linked to results, certificate and validity information.

Calibration Records

Link pre-checks, as-found and as-left results, deviations, certificates and validity dates to the device record. SANAS-accredited options apply only where confirmed for the selected laboratory and scope.

View the Calibration Package

AutoQMS™ · demonstration

Customer review

Controlled document

DEMO-QMS-021

Current

Scheduled quality event

Evidence review

02 Aug 2026

Validation / QIC output

Where configured

Customer controlled

Assigned reviewer and approval remain controlled by the customer.

AutoQMS™

Organise controlled documents, scheduled quality events, validation or QIC outputs and review status within customer-managed approval workflows, where configured.

Measurement Traceability

Keep measurement records traceable from pre-check to certificate.

Connect each device to its calibration history, supporting results, deviations, certificate and validity context so reviewers can see the measurement record behind the reported value.

From Pre-check to Certificate

Record the pre-calibration check, device identity, authorised laboratory work and resulting certificate within one linked history.

Parameters Covered

Temperature / Humidity / Pressure

Certificate-Linked Devices

Keep certificate references, calibration status and validity dates connected to the device and the reports that use its readings.

Results + Deviations

Retain as-found and as-left results, recorded deviations and status changes so authorised reviewers can assess the measurement history.

Accreditation applies only to the laboratory, method and scope stated on the relevant certificate.

Calibrated device linked to pre-check records, result history, certificate and validity status.

Standards with Context

Show where each framework connects to the evidence workflow.

Review standards, regulatory references and customer controls as grouped evidence pathways. Each explanation identifies the supported workflow and its boundary without implying certification.

Regulated Records + GxP

Supports SAHPRA-oriented pharmaceutical monitoring workflows for regulated environments.
Supports GxP readiness, validation, BMS/HVAC monitoring, qualified limits and review packs.
Supports GxP quality workflows and review evidence.
Supports GxP distribution traceability and review evidence.
Supports GxP laboratory records and data-integrity evidence.
Supports electronic record controls, audit trails, authorisation workflows and e-signature evidence.
Supports computerised-system records and controls for GxP environments.

Food, Agriculture + Export

Supports PPECB reporting and traceability workflows for perishable export operations.
Supports HACCP food-safety and critical-control-point monitoring evidence.
Supports FSSC 22000 workflow evidence.
Supports ISO 22000 food-safety management evidence.
Supports GLOBALG.A.P. agricultural production evidence.

Calibration + Measurement

Calibration traceability using SANAS references, certificate links and validity records.
Supports medical laboratory quality-management evidence.
Calibration traceability using NIST references, certificate links and validity records.

ISO Management Systems

Supports quality-management records and review evidence.
Supports environmental-management records and review evidence.
Supports occupational health and safety records and review evidence.
Supports energy-management records and review evidence.
Supports information-security management evidence.

Sector + Statutory Requirements

Supports POPIA-aligned workflows for personal information protection evidence.
Supports drinking-water quality monitoring evidence.
Supports retained monitoring records and review evidence for applicable Mine Health and Safety Act requirements.
Supports retained monitoring records and review evidence for applicable DMRE requirements.

Customer + Internal Controls

Support for custom customer-specific compliance standards.
Support for internal Standard Operating Procedures and quality systems.

Enabling Controls

Spatial and access context

PostGISEnterprise Security

Add spatial context to mapped assets and events, and use authenticated access, permission controls and private deployment options to protect review workflows where configured.

Additional requirements can be assessed during solution planning.

Plan the Evidence Workflow

Build the reporting, traceability and review path around your operation.

Define how records are captured, linked, reviewed and reported across your operation. Nvirosense™ can shape the monitoring and evidence workflow around your devices, requirements and authorised review process.