A robust regulatory framework
to reassure and secure your programs
At PhinC, quality, data integrity, and regulatory compliance
are at the core of how we operate. Our processes and infrastructure are designed to ensure full traceability and protect your data throughout the project.
- 21 CFR Part 11
- GAMP
- Internal audits
- GDPR
Quality Management System (QMS)
A QMS designed to support every aspect of the business and to anticipate and adapt to regulatory, methodological, and organizational changes.
A structured and documented framework
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Activities conducted in accordance with SOPs & MOs Pharmacometrics performed in accordance with validated procedures.
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Compliance with regulatory requirements Processes aligned with applicable regulatory requirements.
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Internal audits & document management Regular audits, version control, archiving, and traceability.
Process monitoring & continuous improvement
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Regulatory compliance Controls and reviews to ensure ongoing compliance of activities.
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Continuous improvement Corrective and preventive actions and optimization of practices.
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Risk management A proactive approach to identify, assess, and control risks.
IT validation & security
A highly reliable IT infrastructure designed to ensure high security standards and meet applicable compliance requirements.
Reliable, secure, and compliant infrastructure
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Regular backups & dual data centers Data redundancy and enhanced data protection.
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21 CFR Part 11 & GAMP compliance Systems aligned with compliance and validation requirements.
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Validation of Computerized Systems Validation of Modeling Computerized Systems
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Periodically Tested Disaster Recovery Plan (DRP) Business continuity in the event of unforeseen events.
Risk management & data protection
Risk management and compliance with contractual and data protection requirements are integral parts of our organizational framework.
Integrated risk management
A proactive approach to identify, prioritize, and control risks.
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Anticipation Risks assessed upfront and monitored over time.
Data protection (GDPR)
A dedicated Data Privacy Officer unsuring the respect of data protection requirements.
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GDPR Compliance Technical and organizational measures in place for data processing management.
Reliable contractual commitments
Legal affairs ensure the robustness of our contractual commitments.
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Clarity & compliance Contractual requirements clearly defined and monitored.
Demonstrated compliance and secure data.
Dual data centers, DRP, system validation, and access control: an IT & Quality foundation designed to meet regulatory requirements and protect your data in all circumstances.