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 validation and equipment qualification
Nubinno System validation and equipment qualification is a comprehensive, multi-phase approach designed to ensure the reliability, quality, and compliance of systems and processes within regulated pharmaceutical industry. The validation process follows a structured lifecycle that includes distinct phases: Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Continuous Validation. By following the IQ, OQ, PQ, and Continuous Validation phases, the Nubinno System validation and equipment qualification ensures high quality, safety, and compliance, contributing to the overall reliability and effectiveness of the processes it supports.
Comprehensive Validation Planning and Risk Management
Developing a comprehensive validation master plan that details each step of the process, we conduct thorough risk assessments to identify and address potential issues. Our dedication to regulatory compliance ensures you remain at the forefront of industry standards. Rely on Nubinno for a validation solution that ensures reliability, quality, and peace of mind
Key benefits and services included:
- Development of a comprehensive validation plan outlining specific activities, acceptance criteria, and documentation needs for computer systems and equipment. This includes:
- Risk Assessment
- User Requirements Specification
- Functional Specification (FS)
- Design Specification
- Installation, Operational, and Performance Qualification
- Final Validation Report
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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