AsssurX Briefing Note
Axendia was recently briefed by Stephanie Ojeda, Director of Product Management, Life Sciences and Manufacturing and Sal Lucido, Executive VP and Co-Founder at AssurX, a privately owned firm. AssurX has over 26 years of experience in providing quality management software to manufacturing and services industries, and more than 15 years of expertise in delivering compliance management software to the energy sector. “Guided by market needs rather than stock market pressures, our company has been fully remote since its inception. Our team is growing with 75 employees after expanding our workforce during the pandemic. Notably, we do not outsource any of our operations. Instead, we offer a comprehensive suite of in-house services that includes implementation, project management, integration, validation, support, and training,” explained Lucido.
Connecting Quality Processes
AssurX integrates a comprehensive array of quality processes to ensure thorough management and compliance across various sectors. The core platform includes essential modules such as Audit Management, Calibration Management, Corrective and Preventive Action (CAPA), Change Control, Complaint Management, Customer Quality, Design Control, Document Management, and Environmental, Health, and Safety (EHS) Issue Management. Additionally, it covers Manufacturing Quality, Management Review, Risk Management, Supplier Quality, and Training Management. For specialized needs, it offers Medical Device and Combination Product Options, including Medical Device Reporting for both FDA and EU requirements. Lastly, the system provides a General Product Option with Patch Compliance Management. “This connectivity ensures that all aspects of quality processes are seamlessly integrated, promoting efficiency, compliance, and continuous improvement within organizations,” explained Ojeda.
The QMS market in life sciences continues to be robust. “We’re attracting new customers by offering a polished and established QMS that stands as a significant upgrade from homegrown systems and manual, paper-based processes. Many prospective clients are looking to migrate from their home-grown systems to a more sophisticated solution that provides comprehensive out-of-the-box functionalities. For customers still relying on manual or paper-based methods for managing their QMS, the transition to our QMS represents a much-needed modernization, effectively moving them out of the “Stone Ages” and into a more efficient, automated era,” added Ojeda.
The AssurX Enterprise Cloud, owned and operated by AssurX, offers options for multi-tenant and dedicated environments, leveraging a proven architecture compared to competitors’ continual redevelopment. It is aligned with industry security standards and is hosted by Switch in a Tier 5® Data Center, which features 100% renewable energy backup systems and military-grade physical security. The hosting provides immediate access to data and hardware and ensures 99.99% uptime. Additionally, AssurX’s cloud and on-premise solutions run the same software with the same interface, making it ideal for hybrid environments and ensuring a seamless transition to 100% cloud.
It’s All About AI
Chatbase AI enhances the AssurX Platform by providing users with an interactive help guide, integrating all content from their website, and incorporating user guides and out-of-the-box (OOTB) solutions. This AI is trained specifically on the AssurX Platform, ensuring a seamless integration. The key benefits of these enhancements include an improved user experience, immediate support, and increased efficiency, all of which contribute to a more effective and user-friendly platform.
“Our AI strategy emphasizes enhancing privacy and security while advancing product development and future process improvements. We’re focusing on current product enhancements, including user guide and search improvements and IMDRF code generation, alongside a roadmap for future developments in corrective action management, complaints management, audits, and regulatory compliance. This strategy aims to ensure robust data protection and continuous advancement in AI-driven quality management processes,” said Lucido.
Leveraging AI and ML to automate the generation of IMDRF (International Medical Device Regulators Forum) codes, the AssurX Platform aims to enhance efficiency and compliance for medical device manufacturers. This addition streamlines the process, ensuring adherence to global regulatory standards while saving time and reducing the risk of human error in code assignment. “By integrating this advanced technology, the platform not only simplifies the compliance process but also enhances accuracy and reliability, providing substantial benefits to our users,” added Lucido.
Future enhancements include:
- AI-driven insights that identify emerging trends in non-conformances and corrective actions, enabling proactive risk mitigation.
- Machine learning algorithms that will analyze historical data to detect patterns in customer complaints, assisting in product improvement and regulatory compliance.
- AI-based auditing tools will enhance the efficiency of compliance audits by automating checklist verification, flagging anomalies, and ensuring adherence to regulatory requirements.
- By continuously monitoring regulatory changes worldwide, the system will proactively update compliance guidelines, helping organizations stay ahead of evolving standards.
Harnessing the power of AI in Quality Management Systems (QMS) will be a game-changer for life science companies seeking to improve quality processes and regulatory compliance.
In Brief
The integration of advanced AI and ML technologies in QMS is set to revolutionize quality processes in the life sciences industry. Companies are transitioning from homegrown and manual systems to sophisticated, automated solutions that enhance efficiency, accuracy, and compliance. The AssurX Enterprise Cloud supports this shift, offering robust, secure, and scalable options for managing quality processes. By leveraging AI-driven insights, machine learning algorithms, and automated auditing tools, organizations can proactively mitigate risks, improve products, and adhere to evolving global regulatory standards. The strategic adoption of AI in QMS has the potential to not only streamline operations but ensure continuous improvement for early adopters in the life sciences industry.
We will continue to provide updates on AssurX as they become available.
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The opinions and analysis expressed in this post reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this post is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This post is not intended to endorse any company or product and should not be attributed as such.