Serialization audit
Enhance your serialization operations with our serialization audit service, designed to ensure your processes align with industry standards and best practices.
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.
Serialization audit
For those who are constantly looking to improve, to identify the gaps and take their serialization and supply chain to the next level. Contact us to find out more on how your processes, people, technology and data stack up against current industry standards.
System integrations and implementations
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.
Market
entry
Unlock global markets with Nubinno Market Entry service, designed to streamline your pharmaceutical product's compliance with serialization and traceability regulations.
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.
Vendor selection for serialization systems
Nubinno specializes in vendor selection for pharmaceutical serialization systems at Level 4–5. Our service helps you identify and evaluate the most suitable solution providers to ensure compliance and transparency across your supply chain.
Change Management
Strengthen your serialization transitions with our change management service, designed to ensure compliance, traceability, and continuity across mergers, acquisitions, and data migrations.
Our references
"Serialization makes drugs safer for patients. Nubinno helped us to register and get ready for serializing of our products for the German market. They also support us with daily challenges of drugs verification from the technical perspective."
"We absolutely recommend the trainings organized by Nubinno. They delivered the training on how to work with L3 and L4 systems, which was organized in a very professional and clear way and the agenda, as well as the materials were fully customized for us."
"Nubinno allows us to promptly solve technical issues on serialization of medicines. It is especially pleasant that technical support is provided in Russian for local colleagues. Thanks to this service, working with serialization has become simple and efficient."
"We were having certain challenges with our Russia Serialization operation in the warehouse. Nubinno team came in the short notice and managed to resolve our issues in a timely manner and very effectively."
“Nubinno provides professional support of our serialization processes and compliance procedures. They helped us to optimize our operations and to get ready for NCA audits and inspections. Nubinno team always goes above and beyond.”
“Nubinno was our partner in preparation of our product serialization. Ever since they are supporting us in daily services of our product serialization environment in a reliable and trustworthy manner.”
“The service provided by Nubinno is over and above what is expected and can be described as exceptional. As a CMO, Siegfried - we thrive and are committed to our core values being Excellence, Passion, Integrity, Quality and Sustainability which can be found within the Nubinno team. This creates the basis for common values, actions and culture providing a firm foundation to ensure success with all customers.”
"Nubinno team has helped us at the critical time when we needed to manage our external partner network quickly. Now we have been working with their team for 3 years on continuous support and evolution of our serialization compliance."
Your partner for global pharma serialization and compliance
From implementation to ongoing support, we provide end-to-end pharma serialization, track and trace, and compliance services (EU FMD, DSCSA). We design, implement, and manage serialization systems for global supply chains, ensuring seamless and compliant operations.
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