The Only Unified
Compliance Platform
Connect Quality, Regulatory, Clinical, and Pharmacovigilance while unifying your teams and data with a purpose-built, AI-powered platform.
One Platform. One Data Model. Complete GxP Coverage.
Ennov’s Unified Compliance Platform powers regulated document and data management across the entire product lifecycle. Built on a single data model, it connects Quality, Regulatory, Clinical, and Pharmacovigilance
No integrations
No Silos No Duplicated Data What Are the Benefits of the Unified Compliance Platform?
- One login, consistent UI/UX across all domains
- AI-powered tools embedded in your workflows
- Reduced total cost of ownership
- Unified master data management
- One source of truth for documents, data, and audit trails
- Lower training needs, faster onboarding
- 100% web-based, 21 CFR Part 11 compliant
- Generate cross-functional insights from a single source of truth
Why Unification Matters
Disconnected systems create delays, risks, and costly rework. Ennov’s Unified Compliance Platform empowers life sciences teams with seamless cross-functional collaboration, faster time to market, harmonized processes across global sites, and real-time visibility—with built-in compliance at every step.
How the Platform Works
Shared data model
or sync issues
Cross-functional workflows
No APIs or integrations required
Role-based access
Secure and scalable
Real-time updates
Immediate system-wide impact
Compliance-ready
21 CFR Part 11, EU GMP Annex 11, ISO standards
Start Anywhere. Scale Without Limits.
Unified Access to All Documents for Improved Efficiency. Unified Management of Enterprise Content.
- Begin with your highest-need function (most start with Quality or Regulatory)
- Expand to Clinical or Pharmacovigilance without replatforming or retraining
- Reuse workflows and master data across functions
- Avoid multiple validation cycles and reduce total cost of ownership
Siloed Systems vs. the Unified Compliance Platform
Scenario 1: Clinical Deviation → Regulatory Update
A protocol deviation is recorded during a trial but isn’t flagged to regulatory in time due to disconnected systems. When the submission is compiled, the missing info triggers questions from health authorities — delaying approval and creating unnecessary rework.
Siloed Systems
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Deviation logged once—but not seen by Regulatory
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Manual re-entry, disconnected tracking
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Submission delayed, compliance risk rises
Unified Compliance Platform
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Deviation recorded once, linked to master data
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Regulatory alerted automatically
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Dossiers flagged instantly, submission starts sooner
The Result?
By connecting clinical and regulatory workflows, Ennov ensures issues are flagged early, reducing rework and accelerating submission timelines — so your treatments reach patients faster.
Scenario: Safety Signal → Labeling Change
A new safety signal is detected by the pharmacovigilance team, but due to siloed systems, regulatory and labeling teams aren’t alerted in time. As a result, label updates are delayed, raising compliance risks and potentially impacting patient safety.
Siloed Systems
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Safety team logs the signal—but Regulatory isn’t alerted
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Manual impact analysis, fragmented updates
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Risk of delay and inconsistency
Unified Compliance Platform
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Signal cascades instantly to Regulatory and Labeling
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Shared master data shows affected regions
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Updates sync across functions, tracked in real time
The Result?
Labeling changes are completed faster and more accurately, reducing compliance risk and supporting timely communication to health authorities and patients.
Case Study: Vetoquinol Scales Without Silos
From QMS to Global GxP Unification
Vetoquinol launched Ennov Quality and quickly unlocked bigger value. As teams experienced faster processes, fewer delays, and stronger compliance, adoption expanded across Regulatory, R&D, HR, and beyond. What began as a QMS rollout became a global transformation—without silos or IT strain.
