Serialization audit
Serialization audit
A serialization audit is a comprehensive evaluation of serialization operations designed to verify compliance with industry standards and best practices within the pharmaceutical sector. This service focuses on four critical pillars of effective serialization: technology, data management, human resources, and operational processes.
Nubinno experts conduct an in-depth analysis of these key areas, identifying strengths as well as opportunities for improvement. Based on the audit findings, a detailed report is provided, highlighting potential compliance gaps and offering targeted optimization recommendations. These recommendations cover technology infrastructure, data governance, team competencies, and operational workflows.
The primary goal is to ensure a fully compliant, robust, and efficient serialization system tailored to the pharmaceutical environment.
Comprehensive operational audit – in-depth analysis of key processes
The serialization audit conducted by Nubinno experts provides a detailed assessment of critical operational elements across four strategic areas:
- Operational processes:We evaluate the effectiveness of compliance procedure implementation and verify alignment with internal documentation and regulatory requirements.
- Human resources: We assess whether employees have received appropriate training and possess comprehensive knowledge of the entire serialization process, extending beyond their individual tasks.
- Technology: We analyze whether the systems in use are optimally tailored to the company’s needs, ensuring operational continuity and high efficiency.
- Data management:We review the handling of critical data, focusing on data integrity and security to minimize the risk of human error.
Nubinno’s expert audit delivers clients full transparency into their operational processes and serves as a foundation for strategic optimization—fully compliant with current regulations and industry best practices.
Key Benefits and comprehensive services included:
- Supply chain compliance overview workshop — Gain expert insights into your supply chain’s regulatory and operational compliance.
- In-depth analysis & detailed reporting covering critical areas:
- Business processes
- Workforce & Personnel
- Technology infrastructure
- Data managment & integrity
- Tailored recommendations & upgrade plans to optimize efficiency, reduce risk, and ensure compliance where necessary.
- Collaborative partnership approach — Nubinno work closely with your team to implement lasting improvements.
Our services
Serialization Experts
Serialization Experts Service delivers agile and highly specialized support tailored to ensure business continuity in all serialization operations. Ensure seamless operation and compliance through our dedicated, multilingual support team and comprehensive technical solutions.
System validation and equipment qualification
Maximize the potential of your systems with Nubinno’s expert System validation and equipment qualification, tailored to meet your specific business needs.
System implementations and integrations
Nubinno specializes in systems implementations and integrations serving as your trusted partner to optimize and ensure your systems work cohesively for a more efficient and compliant operation.
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Vitold
CEO of Nubinno connect.
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