Regulatory Data Quality Management

End-to-end

SPOR Validation

Deterministic SPOR validation with continuous maintenance
controls across SMS, PMS, OMS and RMS.

SPOR Data Quality Layer

Stabilise SPOR data across continuous change.

SPORVIGILANCE validates operational SPOR data from RIM exports or enterprise master data layers, aligning records with regulatory guidance and live EMA sources to protect submission integrity.

  • Deterministic Validation

    Authoritative business rule execution with consistent, repeatable outcomes.

  • Targeted Remediation

    Surface misaligned records without disrupting compliant data.

  • Continuous Regulatory Alignment

    Keep operational SPOR records aligned to evolving EMA standards.

GxP Aligned & Auditable

SPOR Validation

Intelligent dashboards that turn live SPOR validation into decisive insight, and submission confidence.

Regulatory Data Reconciliation

PMS
Alignment

Align internal product data with EMA PMS at portfolio scale. SPORVIGILANCE compares RIM-held medicinal product data against PMS records, turning complex regulatory differences into clear, actionable alignment intelligence.

  • ✔ Compare internal and PMS data at portfolio level.
  • ✔ Identify mismatched, missing and inconsistent values automatically.
  • ✔ Validate and associate PMS identifiers against internal records.
  • ✔ Review differences field-by-field with source values side by side.
  • ✔ Surface gaps across substances, packages and strengths.
  • ✔ Separate confirmed matches from records requiring investigation.
  • ✔ Generate structured reconciliation outputs to support remediation.

High-fidelity RIM-to-PMS comparison for rapid identification and reconciliation of regulatory data discrepancies.

Direct Visibility into EMA Product Data

PMS
Explorer

Explore EMA PMS with regulatory-grade clarity. SPORVIGILANCE provides a streamlined view into EMA PMS, allowing regulatory teams to search and investigate medicinal product data without navigating raw API structures.

  • ✔ Search PMS using recognised product and regulatory identifiers.
  • ✔ Filter searches by PMS ID, product name, xEVMPD ID or MA.
  • ✔ Browse PMS product records through a structured regulatory view.
  • ✔ Explore complete product data, including packages and ingredients.
  • ✔ Translate controlled IDs into readable regulatory terms.
  • ✔ Inspect strengths, dose forms, routes and status data.
  • ✔ Move quickly between portfolio exploration and detailed regulatory investigation.

Explore EMA PMS with regulatory-grade clarity. Search and investigate medicinal product data.

High-Fidelity Regulatory Intelligence

IDMP
Business Rule Validation

End-to-end Chapter 2 Business Rules Validation. SPORVIGILANCE validates entire portfolios in seconds, surfacing compliant and non-compliant fields with precision and full regulatory context.

  • ✔ Multi-product PMS field explorer with field-specific guidance.
  • ✔ Built-in conditional logic, including driver field detection.
  • ✔ High-fidelity regulatory intelligence from a single upload.
  • ✔ Smart close-match suggestions for misaligned RMS terms.
  • ✔ Ensures IDMP data meets eAF, ESMP, and ePI requirements.
  • ✔ Three-level insights dashboard, built for regulated environments.
  • ✔ Maintains high-quality, controlled RIM data that is always submission-ready.

Industry-leading PMS business rule validation built to maintain RIM data as a trusted source of truth.

Authoritative Referential Control

RMS
Term & ID Reconciliation

Compare internal internal RMS extracts and reconcile them against live EMA lists to detect alignment gaps, missing entries, close matches and structural discrepancies.

  • ✔ Upload internal referential extracts for direct comparison with EMA RMS lists.
  • ✔ Identify aligned, misaligned, duplicate and missing terms instantly.
  • ✔ Surface close-match suggestions for near-aligned entries.
  • ✔ Detect inactive or deprecated EMA list entries.
  • ✔ Display list metadata including last modified and last scanned timestamps.
  • ✔ Download reconciliation results or export authoritative EMA lists directly.

RMS validation engineered for submission confidence.

Organisation & Location Integrity

OMS
Organisation Data Alignment

Reconcile ORG and LOC identifiers against authoritative OMS data, ensuring structural alignment, entity validity and controlled change awareness across regulatory records.

  • ✔ Validates ORG-ID and LOC-ID against EMA OMS sources.
  • ✔ Confirms entity existence and identifier accuracy.
  • ✔ Detects inactive, transferred or structurally changed organisations.
  • ✔ Identifies misaligned ORG relationships before submission impact.
  • ✔ Surfaces full metadata including status and last modified indicators.
  • ✔ Enables export of aligned OMS data for regulated downstream use.

Instantly validate OMS records against the live EMA API.

Substance Data Standardisation

SMS
Substance Data Validation

SPORVIGILANCE ensures internal substance data is structurally aligned, classification-ready and compliant with authoritative SPOR definitions before downstream regulatory use.

  • ✔ Aligns internal substance data to authoritative SPOR references.
  • ✔ Prevents portfolio-wide substance fragmentation.
  • ✔ Detects misaligned substance definitions and incomplete data.
  • ✔ Delivers controlled, submission-ready substance master data.
  • ✔ Enables download of detailed validation results for audit and review.
  • ✔ Exports submission-ready golden substance records.

Real-time SMS verification for trusted substance data.

The first purpose-built Chapter 2 validation layer.

Execute full Chapter 2 PMS business logic with embedded conditional dependencies, structured remediation guidance and deterministic outcomes across entire portfolios.

  • Generates structured Validation Assessment reports and field-level export results with precise remediation guidance.
  • Delivers three-tier insight visibility: executive compliance metrics, portfolio-level summaries and multi-field record exploration.
  • Identifies blockers, RMS outliers and cross-field inconsistencies before they impact downstream submissions.
  • Maintains clean, controlled RIM data through deterministic business rule enforcement.

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.