Healthcare & Pharmaceuticals

The healthcare and pharmaceutical industries face an array of strict regulatory mandates that require robust compliance management programs. These include regulations such as:
  • - HIPAA - Governs patient data privacy and security
  • - DSCSA - Outlines track and trace requirements for pharmaceuticals
  • - EU MDR - Medical device compliance standards in Europe
  • - cGMP - Quality system regulations for pharma manufacturing
In addition to avoiding potentially severe penalties for non-compliance, organizations must also mitigate supply chain risks and ensure product quality.

Intelleges provides an enterprise compliance platform purpose-built to address these healthcare and pharma challenges.
Use Cases:
  • - Global pharmaceutical manufacturer uses Intelleges to manage cGMP compliance across 50+ facilities. Real-time visibility enables proactive risk management and accelerated response to health authority audits.
  • - Leading medical device company leverages Intelleges to comply with EU MDR. Automated supplier assessments and documentation management significantly reduces time spent preparing for Notified Body audits.
  • - Multi-hospital health system uses Intelleges to implement cybersecurity controls required by HIPAA. Greatly improved audit readiness and reduced manual workflows.
  • - Serialization and track & trace support to comply with DSCSA requirements
  • - Pedigree management and documentation for DSCSA and wholesale distribution
  • - Automated validation testing and evidence collection
  • - Batch and change management traceability
  • - Supplier risk assessments and ongoing monitoring
  • - Customized audit plans, scheduling and issue tracking
  • - Automatic retention and archiving of audit evidence and training records
  • - Role-based access control and activity logging
  • - Consistent compliance with rapidly evolving healthcare regulations
  • - 60-80% reduction in audit preparation timelines
  • - Lowers compliance program costs by 30-50%
  • - Reduces supply chain risk exposure through real-time insights
  • - Accelerated new product introductions through streamlined change control
  • - Enhanced data security and patient privacy safeguards