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Quality Compliance:
Quality management has a far-reaching impact across all facets of your business, spanning from R&D and clinical trials to manufacturing and distribution. Consolidating quality management within an enterprise management platform streamlines operations, enabling greater efficiency and effectiveness, along with reductions in risks and costs.
This approach is also in harmony with some of your most significant business objectives, such as the introduction of new products, improving patient safety, fostering collaboration with partners, and staying compliant with evolving regulatory requirements.
Minimize the burden, mitigate risks, and trim the expenses associated with quality compliance. NovintiX customized solution offers the capability to automate a single process or enhance your complete quality management system. Built upon leading industry standards, our customized solution delivers closed-loop functionality and seamless integration across various quality processes.
Regulatory Compliance:
Global regulations continue to evolve, with thousands being introduced each year, making compliance both expensive and intricate.
NovintiX’s Regulatory Compliance solutions ensure you remain on course and in command. Our operational framework assists in aligning with industry standards. Our team of digital technology experts aids in independent validation services and the development of regulatory applications. Our approach centers on best practices encompassing information security management, FDA guidelines on system validation, and electronic records and signatures.
Our remediation services focus on identifying and addressing issues, ensuring compliance, and optimizing processes to enhance overall performance and quality.
We specialize in regulatory submissions and approvals, including 510(k) submissions, CE marking, and country-specific filings to ensure compliance with medical device regulations.
Our CAPA management solutions help identify, track, and implement corrective and preventive actions, ensuring continuous improvement and compliance.
We offer expertise in establishing and maintaining robust quality management systems (QMS) to meet regulatory requirements and drive product quality and safety.
Our product quality engineering services focus on optimizing product quality through rigorous testing, validation, and quality assurance processes.
We conduct gap assessments to identify areas of improvement in processes, compliance, and quality management, enabling tailored solutions for excellence.
Empower innovative solutions and provide best in class services to our customers & employees.