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DataOps Suite
The complete platform
Data Quality Monitor
Continuous quality monitoring
ETL Validator
ETL, ELT and migration testing
BI Validator
Dashboard and report testing
Test Data Manager
Compliant synthetic test data
Platform Overview
See how it works

DataOps Suite

Data Quality and Agentic AI platform that validates, reconciles, scores, monitors and remediates data from ingestion to BI and AI.

Why one platform

Agentic AI-powered test and rule creation
Agents generate data quality rules, validation tests and SQL from prompts, with your approval.
Data quality score per dataset
Shows the current score, what changed since the last run and the failing records behind it.
Validation and observability inside the pipeline
Every load is compared with its source, transformations are tested against business logic, and freshness, volume and schema changes are monitored.
Reports that match the source
Dashboard figures are compared with the source data behind them before users see them.
Test data without real records
Synthetic data that mirrors production replaces sensitive records in test environments.
Quality gates for releases
Pipeline and report changes are tested before they go to production.

Data Quality Monitor

Continuously profiles, validates and scores enterprise data, with Agentic AI that recommends rules and flags anomalies, so analytics and AI run on trusted data.

Capabilities

AI-recommended DQ rules and scoring
Agents suggest completeness, validity and uniqueness rules, with scores down to the column.
Data profiling
Analyzes distributions, patterns and frequencies to surface outliers.
AI-based observability
Agents monitor pipelines end to end, detect anomalies and suggest fixes.
Data catalog
Organizes models and tables in one catalog, with AI-drafted descriptions.
Data lineage
Traces data from origin to destination through every transformation.
Data quality issue tracking
Assigns every failing record to an owner and tracks it to resolution.

ETL Validator

Automates ETL/ELT testing, with Agentic AI that builds tests from mapping docs, confirming every record arrives complete, accurate and correctly transformed.

Capabilities

AI-generated ETL tests
Turns mapping docs into checks for joins, transforms and edge cases.
Source-to-target validation
Matches loaded data to the source, down to record counts and required fields.
Transformation validation
Verifies business logic with SQL, Python or Scala.
Migration validation
Checks schema, row counts and integrity for cloud migrations.
Metadata change audit
Catches schema and metadata discrepancies before they break pipelines.
Root cause and adaptive tests
Pinpoints where data broke, and agents update tests when mappings change.

BI Validator

Automates testing and governance for Power BI, Tableau and Oracle Analytics, with Agentic AI that builds tests from plain English and keeps reports accurate and reliable.

Capabilities

AI-created BI tests
Describe a test scenario in plain English, and agents build it.
Visual-to-source comparison
Compares the data behind every visual to the source using auto-generated SQL.
Regression and upgrade checks
Pixel-level comparisons across environments, with AI summaries of what changed.
Measure logic checks
Converts BI measures and calculations to SQL to confirm KPI logic.
Performance and load testing
Simulates concurrent users and measures load and refresh times.
BI governance
Finds unused measures, duplicate reports and orphaned tables.

Test Data Manager

Uses Agentic AI to detect and mask sensitive data and generate synthetic data that mirrors production, so teams can test without exposing real records.

Capabilities

AI synthetic data generation
Learns patterns from a small sample to create production-like data.
PII discovery and masking
Detects PII and PHI and replaces it with realistic fake values.
Relationship-aware data
Keeps linked tables connected with referential integrity.
Millions of records in minutes
Scales for load, stress and performance testing.
Multi-format output
CSV, Parquet or JSON, or loaded straight into test databases.
Compliant by design
Cloud or on-prem, supporting GDPR and HIPAA requirements.
Data Quality Use Case
The problem to solve
Cloud platforms
Warehouses, lakes and CRM
BI and analytics
Dashboards and reports
ROI calculator
Estimate the time and cost youโ€™ll save.
Financial services
SOX, BCBS 239 and NAIC MAR
Healthcare
HIPAA, EHR migration and APCD
Life sciences
GxP and 21 CFR Part 11
Manufacturing
ERP migration and supplier data
Retail and utilities
Settlement, pricing and NERC CIP
Higher education
FERPA, IPEDS and research data

Banking, Financial Services, and Insurance (BFSI)

Stop reporting errors before examiners find them, with every number traced from core system to board dashboard.

How Datagaps helps

Core platform migrations
Cut over banking and insurance platforms, including mainframe to cloud, without losing a record.
Regulatory reporting
Hold submissions until the data meets quality thresholds.
Financial reconciliation
Match GL to subledger automatically, with every break flagged.
Risk and credit data
Catch drift before risk, lending and pricing models degrade.
Dashboard attestation
Prove capital and board dashboards match the warehouse.

Healthcare

Keep claims and clinical data accurate through every migration, without exposing patient records in testing.

How Datagaps helps

EHR migrations
Confirm every record survives the move to Epic, Cerner or Oracle Health.
Claims data quality
Catch errors in claims and remittance feeds as they arrive.
APCD submissions
Check every file against state templates before you submit.
Clinical dashboards
Catch KPI and report changes after every refresh.
Provider directories
Keep provider listings accurate, current and audit-ready.

Life Sciences

Catch issues in clinical and real-world data before submission, and keep trial subject data out of test environments.

How Datagaps helps

Clinical data migrations
Move EDC, CTMS and LIMS data to the cloud without losses.
CRM migrations
Keep rebate calculations right through Veeva and Salesforce moves.
Pharmacovigilance data
Catch adverse event data issues before regulatory submission.
Commercial and clinical dashboards
Trace every KPI back to source clinical and lab records.
De-identified trial data
Keep subject data out of test, analytics and AI environments.

Manufacturing

Avoid broken ERP cutovers and supplier overpayments, and catch sensor drift before it hits production.

How Datagaps helps

ERP migrations
Move BOM, inventory and financial data across Oracle, SAP and cloud without breaks.
Supplier reconciliation
Catch overpayments and duplicate invoices with three-way PO, ASN and invoice matching.
Sensor data quality
Catch drift before it skews predictive maintenance and yield models.
Operations dashboards
Catch report breaks after every release or upgrade.
Safe ERP test data
Keep supplier pricing and production volumes out of lower environments.

Retail and Utilities

Catch settlement, inventory and pricing errors before your customers or regulators do.

How Datagaps helps

Settlement reconciliation
Match marketplace payout files to the general ledger, record by record.
Inventory accuracy
Keep POS, ERP and warehouse numbers in sync.
Pricing and promotions
Catch price and promotion mismatches across channels.
Reliability dashboards
Keep SAIDI and SAIFI reliability reporting accurate.
BI under load
Make sure reports hold up for thousands of concurrent users.

Higher Education & Research

Get enrollment, financial-aid and transcript data right before SIS cutover, before students feel it.

How Datagaps helps

SIS migrations
Validate moves from Banner or PeopleSoft to Workday Student or Ellucian.
Financial-aid reconciliation
Match aid and Bursar data to the general ledger.
Enrollment reporting
Keep census and admissions dashboards consistent from cycle to cycle.
Federal reporting
Monitor data quality ahead of IPEDS submissions.
Safe student data
Test and train AI without exposing real student records.

Trusted Data Summit

A practitioner summit focused on the validation, observability, governance, and reconciliation practices that determine whether enterprise data is ready for AI.

Save Your Spot
Nov 19th, 2026
Technology Partners
Cloud, data and BI platforms
SI Partners
Consulting and implementation

Become a partner

Resell, implement or co-deliver

Technology Partners

Datagaps works natively with the cloud, data and BI platforms your teams already run.

Our technology partners

SI Partners

Consulting and integration firms that deliver Datagaps validation for enterprise clients worldwide.

Our SI partners

Solutions

Use cases

Cloud platforms

BI and analytics

Home Industries Life Sciences

Validation-Grade Data Assurance for Pharma,
Biotech, and Medical Device Companies

One platform validates every clinical and commercial data migration, monitors real-world data quality continuously,
and generates de-identified synthetic trial data built for 21 CFR Part 11, GAMP 5, and GxP

The Challenges

Five Business Risks Every Life Sciences Team Faces

What weak data validation costs life sciences in regulatory risk, revenue leakage,pharma and biotech.

Clinical Trial Data Migration Risk for Life Sciences

Clinical Trial Data Migration Risk

What does it cost when study data or commercial records don't reconcile after go-live?

Every pharma company is facing a platform migration right now: legacy EDC and CTMS into Veeva Vault, and a commercial CRM move that's reshaping field operations. Migration is where trust breaks. A single undetected mapping error can turn into an FDA finding or a broken rebate payout downstream.

83%

of clinical data migration projects fail or overrun; FDA findings from migration errors can delay approvals by years

21 CFR Part 11 & GAMP 5 Validation Evidence For Life Sciences

21 CFR Part 11 & GAMP 5 Validation Evidence

What's the cost of a computer system validation that can't survive an FDA inspection?

FDA mandates computer system validation with complete audit trails, electronic records integrity, and documented evidence. Without automated validation, every system change demands weeks of manual IQOQ/PQ protocol execution.

$300M+

in FDA consent decrees annually tied to data-integrity and computer-system-validation failures

Pharmacovigilance & Adverse Event Data Quality for Life Sciences

Pharmacovigilance & Adverse Event Data Quality

What's the cost of an incomplete or late adverse event report reaching regulators?

Adverse event reporting is a regulatory obligation with zero tolerance for delays. When FAERS or EudraVigilance submission data has completeness or timeliness gaps, the consequences are Warning Letters, import bans, and EU GVP fines.

โ‚ฌ20M

maximum EU GVP penalty per violation; US FDA can issue Warning Letters and import bans for PV failures

Real-World Data Quality for RWE Studies For Life Sciences

Real-World Data Quality for RWE Studies

What's the cost of an RWE submission the FDA can't trust?

Real-World Evidence is increasingly required for label expansions, regulatory submissions, and HTA dossiers. But poor source data quality and inconsistent coding invalidate RWE submissions before they reach FDA reviewers.

67%

of RWE studies delayed or rejected due to inadequate source data quality documentation

Patient & Subject Data in Non-Production Environments For Life Sciences

Patient & Subject Data in Non-Production Environments

What's the cost of trial subject data appearing in a test environment?

GCP, GDPR, HIPAA, and 21 CFR Part 11 all mandate strict separation of subject-level data from non-production environments. Yet trial subject PII routinely appears in QA, UAT, and development - a compliance exposure most teams discover only during an audit.

72%

of biopharma companies have trial subject data in at least one non-production environment

The Platform

How DataOps Suite Solves It

Each product maps directly to a life sciences data validation problem โ€” deployed independently or as a unified, GxP-ready suite.

ETL Validator for Industry icon

ETL Validator

Solves: Clinical & commercial system migration

Record-level, non-sampled reconciliation across EDC, CTMS, LIMS, and legacy system migrations. AI-generated test cases produce IQ/OQ/PQ-ready validation evidence, cutting manual protocol execution time significantly

21 CFR Part 11
EDC / CTMS Migration
LIMS Validation
BI Validator for Industry Icon

BI Validator

Solves: Regulatory & clinical analytics dashboards

Cell-level regression across Power BI, Tableau, and other BI Platforms. Cross-layer traceability links every KPI to its source CRF or lab record โ€” the audit chain FDA inspectors expect during data-integrity reviews.

DQMF Compliance
Clinical Dashboards
Audit Traceability
Data Quality Monitor for Industry Icon

Data Quality Monitor

Solves: Pharmacovigilance & RWD quality

Continuous six-dimension DQ monitoring on adverse event, clinical, and real-world data feeds. Catches completeness gaps, coding inconsistencies, and timeliness failures before they reach FAERS, EudraVigilance, or FDA regulatory submissions.

Continuous Monitoring
FAERS / EudraVigilance
RWD Quality
Test Data Manager for Industry icon

Test Data Manager

Solves: Trial subject data in non-production

GDPR- and HIPAA-aligned deterministic masking generates realistic synthetic trial subject and patient data without exposing real PII โ€” letting AI/ML and analytics teams work with statistically representative clinical data safely.

AI / ML Ready
GCP / GDPR Masking
Synthetic Trial Data
Full Platform DataOps Suite for Industry Call to Action Icon

See the Full Platform

Deploy any product standalone or connect all five with shared lineage, unified audit trails, and a single compliance dashboard.

Proven Outcomes

Impact Across Life Sciences Teams

60%

Faster Validation Cycles

AI-generated test cases cut IQOQ/PQ protocol execution time by over half

100%

Record-Level Coverage

Every clinical record not just sample checked, not a statistical subset

Zero

Real PII in Test Labs

GCP-aligned masking removes the need for trial subject data in non-production environments

FDA-Ready

Validation Evidence

IQ/OQ/PQ-compatible audit trails generated automatically for every validation run

Use Cases

Life Sciences Use Cases by Product

Clinical Data Migration (EDC / CTMS / LIMS โ†’ Cloud)

100% source-to-target reconciliation for migrations to Veeva Vault, Medidata Rave, or Oracle Health Sciences. AI-generated test cases produce IQ/OQ/PQ-ready evidence, cutting manual CSV protocol effort by over half.

Veeva / Salesforce CRM Migration Validation

Source-to-target reconciliation for Veeva-to-Vault-CRM and Salesforce Life Sciences Cloud migrations. Validates data flows from CRM through lake house to downstream HCP-facing applications ensuring the platform split doesn't break operations or rebate calculations.

Commercial & Clinical Dashboard Regression

Visual regression and pixel-to-pixel comparison across territory sales dashboards, clinical KPI reports, and QBR presentations on Power BI, Tableau, and other BI Platforms

Regulatory Report & Audit Traceability

Cross-layer traceability links every KPI to its source CRF, lab record, or commercial data mart the audit chain FDA inspectors expect during data integrity reviews.

Pharmacovigilance & FAERS Quality Monitoring

Continuous six-dimension quality monitoring on adverse event and safety data feeds. Catches completeness gaps, coding inconsistencies, and timeliness failures before they reach FAERS or EudraVigilance.

Rebates Process & Commercial Data Validation

Validates distributor sales data at ingestion, reconciles eligibility rules and unit calculations, and flags anomalies duplicate claims, missing NDC codes, volume spikes before rebate payouts are calculated.

GCP/GDPR-Safe Synthetic Trial Data

Deterministic, reversible masking generates realistic synthetic trial subject and patient data without exposing real PII letting AI/ML and analytics teams work with statistically representative clinical data safely.

AI/ML Training Data for Drug Discovery

Privacy-safe synthetic datasets for predictive modeling, compound screening, and clinical decision support without copying trial subject data into development environments.

GxP-Ready Unified Compliance Platform

Single audit trail covering 21 CFR Part 11, GAMP 5, GDPR, and GxP requirements. IQ/OQ/PQ-compatible evidence generated automatically for every validation run.

AI-Generated Test Cases for Life Sciences Pipelines

Auto-generate validation rules from EDC metadata schemas, mapping documents, and transformation specs. Self-healing tests survive schema changes across system upgrades and study amendments.

Proof Points

Customer Evidence in Life Sciences

Scaling Power BI Testing Automation

Automated KPI card-to-trend-chart validation across 30+ production pipelines for multiple pharma clients. 70% time savings vs. manual validation, 80% reduction in turnaround time, with reusable template projects eliminating rebuild redundancy.

Automated Tableau Testing for Reliable Reports

Automated regression, performance, and security testing across six Tableau production environments serving 11,000 users. 45-55% faster upgrade testing, 25% reduction in functional testing time, and 20% overall TCO reduction."

Get Started Today

Experience Datagaps Live - Trust your Data With Confidence

Our team will run a live demo against your specific use case your stack, your data problem, your pipeline.

SOC 2 Type II certified | ISO 27001 certified | No credit card required for trial | Your data never leaves your environment

FAQs: Life Science Services

 Common questions from Enterprise Buyers

How does Datagaps support GxP and 21 CFR Part 11 validated data requirements?

DataOps Suite runs inside a validated, audit-documented environment aligned to GxP and 21 CFR Part 11, with every validation run logged for inspection. See the full compliance approach on our Compliance Solutions page, and how it applies to life sciences specifically on our Life Sciences Data Testing page.

Can Datagaps reconcile clinical trial data across systems at real research scale?

Yes โ€” Data Reconciliation and ETL Validator validate record-, field-, and aggregate-level matches across EDC, LIMS, and CTMS systems without sampling, so discrepancies surface before they reach a regulatory submission. Our App Integration Data Testing guide covers the full cross-system validation approach.

Does Datagaps generate de-identified data that preserves statistical validity for research use?

Yes. Test Data Manager de-identifies patient and trial data while preserving referential integrity and statistical distribution, so research and model-training datasets stay usable without exposing PHI.

How does Datagaps help in AI powered drug discovery or clinical decision support?

Reliable AI starts with AI-ready data โ€” Data Quality Monitor continuously profiles and scores the datasets feeding drug-discovery and clinical-decision models, catching drift before it degrades model output. Our Data Quality for AI Readiness guide covers the full framework behind that scoring.

Can Datagaps help with the operational burden of profiling large pharma datasets?

Yes โ€” Data Quality Monitor automates column-, pattern-, and dependency-level profiling across large pharma datasets instead of leaving it to manual spot-checks. See the methodology in our blog, Data Profiling in ETL: Types and 5 Best Practices.

Is Datagaps deployable in a fully validated, on-prem, or air-gapped environment?

Yes โ€” DataOps Suite deploys entirely on-prem or in an air-gapped environment with no data leaving your perimeter, and every run is logged for validation-state audits. See the deployment and controls detail on our Compliance Solutions page, or request a demo to review your specific environment.

Learn More About Datagaps Solutions

See how enterprises are solving complex data challenges and achieving measurable ROI

Datagaps Partnership with Vega IT to Help Organisations Build Trusted Data Foundations for Digital and AI Transformation

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Datagaps and Vega IT Partner to Bring Trusted Data Foundations to Digital and AI Transformation

Accelerating Databricks Lakehouse: Automated Migration Validation and Trusted Analytics

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Accelerating Databricks Lakehouse: Automated Migration Validation and Trusted Analytics

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Learn how leading enterprises build AI-ready data with continuous validation, automated testing and proactive quality monitoring.

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Data Quality Monitor

Continuously assess, score, and improve your enterprise data quality using rule-based and AI-powered validation
Automated Data Quality Checks at Scale

Validate uniqueness, completeness, domain accuracy, and detect orphan records.

AI-Driven Anomaly Detection and Alerts

Identify data drift and outliers using ML-based statistical methods and IQR-based profiling.

Low-Code Rule Configuration with Data Rule Wizard

Create and deploy validation rules quickly without coding, even across large datasets.

Graphical Scoring and Monitoring Dashboard

Visualize data quality trends across models, tables, and records with actionable insights.

CI/CD and Cloud Integration Ready

Enable continuous validation across pipelines using integrated APIs and DevOps compatibility.

Test Data Manager

Generate high-quality synthetic test data securely while maintaining regulatory compliance with HIPAA, GDPR, and CCPA
AI-Powered Synthetic Test Data Generation

Automatically create realistic data based on patterns in production while masking PII/PHI.

Reduced Cost and Time for Test Data Preparation

Eliminate manual rule-writing and speed up test readiness for complex use cases.

Support for Diverse Data Formats and Models

Generate millions of records in JSON, XML, CSV, relational, or hierarchical formats.

Secure, Policy-Driven Data Masking

Ensure sensitive fields are protected using deterministic, reversible, or random masking.

Flexible Deployment Across Cloud or On-Prem

Deploy within your secure environment and integrate into automated pipelines seamlessly.

ETL Testing

Maximize the efficiency, quality, and reliability of your data pipelines through intelligent automation, validation, and scalability.
100% Data Validation Across Pipelines

Validate billions of records using Spark-powered parallel execution across on-prem and cloud sources.

Accelerated Migration and QA Cycles

Reduce migration testing time by up to 60% and QA costs by 30% with automated workflows.

Automated Metadata and Transformation Testing

Detect schema mismatches and ensure business rules are correctly applied via AI-assisted validation.

Seamless Collaboration and Governance

Enable role-based access, ALM integration, and shareable web reports to unify cross-team efforts.

Low-Code/No-Code Test Creation with AI

Empower both technical and business users to build, schedule, and execute validations using prompt-based automation.

BI Validator

Ensure accuracy, performance, and security of your Business Intelligence dashboards and reports across platforms like Tableau, Power BI, and Oracle Analytics
Automated Regression Testing Across BI Reports

Detect broken visuals or logic changes post-upgrade and data refreshes.

Cross-Platform Validation of Reports and Dashboards

Compare visuals and data across environments and BI tools with zero manual effort.

Performance and Load Testing for BI Assets

Simulate concurrent user access to measure response times and report load failures.

Access and Security Validation

Ensure only authorized groups have access to the correct records and reports.

Aesthetic and Metadata Change Detection

Identify formatting inconsistencies, filter changes, and layout drift with each release.

Products

product_menu_icon01

DataOps Suite

Intelligent Data Validation and Analytics Testing Platform with Agentic AI.

ETL Validator automated ETL testing tool

ETL Validator

Automated Data Validation and ETL Testing with Agentic AI.

BI Validator automated BI testing tool

BI Validator

Smarter BI Validation For Power BI, Tableau, Oracle Analytics โ€“ Accelerated by AI Agents.

Data Quality Monitor software

DQ Monitor

Proactive Data Quality with Agentic AI โ€“ Predict, Prevent, Govern.

Test Data Manager software

Test Data Manager

Generate compliant and realistic test data for all your testing needs, enabled by Agentic AI.

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