Built by Former EMA and MHRA IDMP Specialists

Precision Validation for

Safer Medicines

Unified SPOR Governance

Explore Platform
SPOR Data Alignment and Governance Submission-Ready Golden Records

Automated SPOR
 Quality Control and
Regulatory Intelligence.

A unified SPOR Governance Platform delivering true end-to-end PMS business rule validation, with OMS, RMS, and SMS standardisation, lookups, and list change monitoring. Transform a single RIM export into high-fidelity regulatory intelligence, enabling assured submissions, sustained compliance, seamless migrations, and continuous SPOR master data maintenance.

Featuring a breakthrough proprietary CO₂e analytics engine that quantifies product environmental impact, transforming regulatory data into actionable ESG intelligence.

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SPORVIGILANCE™ is powered by a purpose-built,
EMA-linked deterministic GxP validation engine.

Unified SPOR Governance Platform

End-to-end
SPOR Validation

Validate Substances, Products, Organisations, and Referentials against the complete EMA record set. Purpose-built to support continuous SPOR data quality maintenance across enterprise portfolios.

  • ✔ End-to-end Chapter 2 PMS Business Rules Validation.
  • ✔ Validates internal SPOR records against live EMA sources via API.
  • ✔ Isolates duplicates and mismatches to support rapid remediation.
  • ✔ Surfaces critical metadata, including last-modified timestamps.
  • ✔ Significantly reduces manual effort through automated workflows.
  • ✔ Supports RIM migrations and ongoing quality assurance.
  • ✔ Produces EMA-aligned golden-records on demand.
Discover: SPOR Validation →

A single operational control layer for governing SPOR data end to end. Continuously, consistently, and at scale.

SPOR Master Data Governance Powerhouse

SPORVIGILANCE transforms SPOR data into a governed, submission-ready asset, purpose-built for enterprise migrations and continuous QA. Portfolio-wide PMS Chapter 2 validation is delivered in seconds using authoritative business rules and embedded conditional logic.
By comparing internal records against live EMA sources, SPORVIGILANCE detects drift, confirms alignment, and enables high-confidence golden record bulk exports, giving regulatory teams lasting control over SPOR master data and submission readiness.

Global IDMP Progress Monitoring
Health Authority IDMP Alignment
Interactive PMS Data Elements
SPOR Monitor
Reference Data Change Tracking

SPOR Monitor

SPOR Monitor delivers real-time oversight of RMS referential updates and OMS location changes, capturing a detailed change log that enables proactive governance, impact assessment, and regulatory readiness at scale.

  • ✔ Detect changes across EMA RMS referential datasets.
  • ✔ Review and export RMS term modifications, and status changes.
  • ✔ Last modified and most recent RMS scan timestamps.
  • ✔ Identify changes to tracked OMS locations over time.
  • ✔ Submission accuracy through manufacturer change awareness.
  • ✔ Simplify governance across reference data changes.
Discover: SPOR Monitor →

Real-time visibility into RMS and OMS reference data changes, with structured insight into their impact.

Accelerated Data Resolution

SPOR Lookup

SPOR Lookup enables fast, reliable access to SMS, OMS, and RMS data, allowing teams to quickly find, verify, and reference SPOR information with confidence.

  • ✔ Instantly verify terms, locations, statuses, and reference values.
  • ✔ Reduce time spent searching across multiple SPOR sources.
  • ✔ Direct linkage between RMS lists and PMS fields.
  • ✔ Resolve data questions ahead of regulatory activities.
  • ✔ Increase confidence in referenced SPOR data.
  • ✔ Select multiple reference entries and export for downstream resolution.
Discover: SPOR Lookup →

Unified access to SPOR data domains, supporting accurate search, validation, and export of reference information.

SPOR Environmental Intelligence

CO₂e IDMP
 Analytics

SPORVIGILANCE delivers automated greenhouse gas analysis directly from validated PMS data, enabling organisations to quantify environmental impact at product and portfolio level with confidence.

Measure

  • ✔ Calculate CO₂e per unit based on structured SPOR attributes.
  • ✔ Generate portfolio-level emissions insights instantly.

Analyse

  • ✔ Identify high-impact dose forms, storage, and device categories.
  • ✔ Compare environmental impact across product variations.

Report & Govern

  • ✔ Support ESG reporting with traceable, data-driven metrics.
  • ✔ Integrate sustainability analysis into regulatory data governance.
Discover: CO₂e IDMP Analytics →

Security and Data Handling.

Engineered for IDMP-grade data integrity, built on ISO standards.

  • No persistent storage, files processed in‑session.
  • Deterministic rule execution to ensure consistent, repeatable outcomes.
  • Versioned validation logic with fully auditable exports.
  • GAMP 5 GxP-aligned architecture built for regulated use.

Experience Precision Validation

See SPORVIGILANCE in action as we run a live, end-to-end validation on your data, revealing compliance status, data quality gaps, and submission readiness in real time.