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Regulatory Affairs Technology at RAPS Regulatory Convergence 2017 (Part 2)

by Arazy Group | Sep 09, 2017

This is the second post of a 3-part series featuring useful technologies for medical device regulatory affairs professionals at RAPS 2017, highlighting SaaS and software solutions. The first article, which focused on compliance review and validation tools, can be found here. The third and final article, featuring innovative data services, will be published tomorrow.

Software and SaaS solutions are a critical part of the modern regulatory affairs professional’s toolkit. Securing approval for a medical device can take years, and often involves sophisticated coordination between developers, CROs and regulatory bodies. Once the device has been approved, there are ongoing demands for compliance management, audits and complaints.

Due to this complexity, IT systems have become essential to managing the voluminous data and documentation requirements of the regulatory process. In this post, we will highlight three useful software tools you may want to explore at RAPS 2017.

Veeva – Vault Suite (Booth XX)

Veeva’s Vault Suite is a cloud-based enterprise content management platform for life science and medical device companies.

Historically, medical device companies have often used on-premise IT systems customized for each department. The regulatory, clinical, quality and marketing staff would each have its own siloed system for content management, making it difficult to coordinate documentation and information between departments.

Veeva Vault is a suite of applications that offers a single source of truth for regulated information across the organization. As a true cloud-based solution, Vault allows all departments to have access to the same unified system, thereby eliminating system, location and country silos.

While other applications focus on managing either content or data, Vault is a solution that can manage both on a single platform. This greatly streamlines the information management process, ensuring content and data stay current across the entire development cycle.

Biovia – QUMAS Compliance Platform (Booth XX)

Biovia develops the QUMAS Compliance Platform, a closed-loop compliance solution that consolidates document and process management across the entire enterprise.

Many medical device companies employ point solutions that address specific compliance challenges. While these applications may perform one function very well, they cannot be integrated with each other, making it cumbersome to manage the overall process. This increases the risk of human error, raises the cost of end-user training, and creates significant process inefficiencies.

QUMAS Compliance provides a single end-to-end solution for the entire compliance cycle, eliminating the costs of managing disparate applications. By standardizing and automating regulatory processes, QUMAS improves productivity while reducing compliance risk.

QUMAS is designed for compliance best practices. For example, it has Read and Understood and E-Signature functionality (21 CFR Part 11) built-in, not plugged-in, enhancing usability for this required regulatory standard. The platform can also be configured to enforce content management practices in line with the requirements of global regulatory agencies such as the FDA.

Arazy Group – LICENSALE.COM (Booth 300)

Arazy Group will also be exhibiting LICENSALE.COM®, the only fully integrated cloud-based global market access and product registration system for medical and IVD devices.

LICENSALE.COM® is built on the proprietary Global Regulatory Intelligence Management System (GRIMS), which handles all aspects of the product registration process and ensures that all applications utilize the most current regulatory requirements for each device type and market.

Multiple experts review your submitted documents, ensuring compliance with local requirements before the system generates a comprehensive set of submission files. The files are submitted to the country’s FDA agency by Arazy Group’s Local Authorized Representative office, resulting in a pre-market approval that is owned by the manufacturer rather than a distributor.  LICENSALE.COM® continues to manage amendments, renewals and transfers of the product’s licensing throughout its entire lifecycle.

Implementing state-of-the-art technology and processes, LICENSALE.COM® has been proven to reduce time to market and overall market approval expenses by 50%, getting products to market months ahead of any current alternative. Clients can simply log into the online user interface, select their markets of interest, and walk through an easy step-by-step registration process.

LICENSALE.COM® supports market registration in 100+ countries. Over the past 4 years, it has been rapidly adopted across the world by medical device companies of all sizes.


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