Sparta Systems today announced the addition of product registration tracking to its 123Compliance quality management system (QMS) software. The new functionality will allow regulatory affairs professionals to significantly reduce the time, cost, and resources needed to track and manage product submissions with regulatory agencies around the globe. This allows companies to more easily bring products to market, and comply with regulatory agencies throughout the product’s life cycle.
Product registration is a critical and yet costly, difficult, and time-consuming burden for companies in regulated industries like pharmaceutical, medical device, and chemical manufacturing. By automating registration tracking activities via 123Compliance, regulatory affairs professionals can increase speed to market and compliance for new and existing products. These operational efficiency gains will make it less expensive for companies to bring products to market, and help them avoid fines and products being recalled due to expired or incomplete registrations.
Since 123Compliance is cloud-based and built on the Salesforce App Cloud platform, it is fully validated and there is no need for companies to manage IT infrastructure. Additionally, regulatory affairs colleagues from around the world can more easily collaborate using an integrated end-to-end system.
Key features of the 123Compliance product registration tracking include:
• A searchable catalog of all registered products and their status;
• Re-usable template and timeline for actions needed for registration activities;
• Document repository for all submission documents and dossiers to make registration as efficient as possible;
• Workflow driven submission process;
• Granular reporting capabilities that provide high transparency into state of compliance across product and region.
The new regulatory tracking capability of 123Compliance is another important piece in the framework of the Quality Business Network (QBN). In this model, all quality stakeholders, including manufacturers, suppliers, distributors and regulators, are connected across a global digital ecosystem for enhanced visibility, collaboration, efficiency, compliance and risk reduction.
“Staying on top of registration requirements for multiple product lines, in multiple countries, can be difficult for even the most highly organized companies,” said Eileen Martinson, CEO of Sparta Systems. “By adding registration tracking to 123Compliance, we are opening up this important capability to a much wider market. This product update furthers Sparta’s vision of igniting the Quality Business Network connecting regulatory affairs professional with regulatory agencies, and increasing collaboration, transparency, and efficiency.
About Sparta Systems
Sparta Systems (spartasystems.com), an industry pioneer and global leading provider of enterprise quality management software (EQMS) solutions, enables businesses to safely and efficiently deliver their products to market. Its TrackWise EQMS, a trusted standard among highly regulated industries, is used by quality, manufacturing and regulatory affairs professionals to manage compliance, reduce risk and improve safety across the global enterprise. Headquartered in Hamilton, N.J. and with locations across Europe and Asia, Sparta Systems maintains an extensive install base in the pharmaceutical and biotechnology, medical device, electronics manufacturing and consumer products markets.
Contact: Dave Heffernan - SHIFT Communications for Sparta Systems