The healthcare and pharmaceutical industries face an array of strict regulatory mandates that require robust compliance management programs. These include regulations such as:
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- HIPAA - Governs patient data privacy and security
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- DSCSA - Outlines track and trace requirements for pharmaceuticals
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- EU MDR - Medical device compliance standards in Europe
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- 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:
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- 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.
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- 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.
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- Multi-hospital health system uses Intelleges to implement cybersecurity controls required by HIPAA. Greatly improved audit readiness and reduced manual workflows.
Capabilities:
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- Serialization and track & trace support to comply with DSCSA requirements
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- Pedigree management and documentation for DSCSA and wholesale distribution
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- Automated validation testing and evidence collection
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- Batch and change management traceability
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- Supplier risk assessments and ongoing monitoring
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- Customized audit plans, scheduling and issue tracking
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- Automatic retention and archiving of audit evidence and training records
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- Role-based access control and activity logging
Benefits:
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- Consistent compliance with rapidly evolving healthcare regulations
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- 60-80% reduction in audit preparation timelines
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- Lowers compliance program costs by 30-50%
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- Reduces supply chain risk exposure through real-time insights
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- Accelerated new product introductions through streamlined change control
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- Enhanced data security and patient privacy safeguards
