The massive amount of time you spend keeping track of product registrations and global regulations and standards is time you can’t get back. You know there has to be a better way. Bringing a product to market will never be easy, but with the right plan, it can be a whole lot simpler and faster.
From lab notes to CAD designs and recipes to prototypes, the amount of information required to compile complex agency submissions and manage multi-country registrations can be staggering. Half the battle for regulatory teams is finding, collecting and formatting this huge volume of data and documentation that’s often confined within departmental and system silos – and worse yet, often in paper format. Companies that want to thrive in the global marketplace need to break down these silos by implementing a truly digital, integrated and end-to-end regulatory information management (RIM) and tracking system.
With paper out of the mix, regulatory teams can shift their focus to establishing a clear registrations and submissions strategy and designing better processes to achieve simultaneous global approval more efficiently. MasterControl Regulatory Excellence allows organizations to create core master dossiers that can be easily tailored to meet country-specific requirements and automate version control to ensure that dossiers are up to date throughout the entire product life cycle.
Achieving product registration and market clearance is just the beginning – you must also be ready and able to quickly scale up production while ensuring accurate transfer of and compliance with country-level product specifications. The MasterControl RIM solution natively connects with our quality management system (QMS), allowing critical content to transfer seamlessly and harmonizing regulatory and quality data.
Explore the following topics: regulatory information management (RIM) system, premarket approval (PMA), 510(k) and eCTD submissions management, global registrations life cycle management, seamless quality management system (QMS) integration.
Explore the following topics: industry-leading enterprise quality management system (QMS), documents and change control, integrated training and exams, robust CAPA and audits, risk mitigation.
Die MasterControl Platform bildet die Grundlage für das komplette Produktqualitätsmanagement – Sie können etwa Anwendungen verbinden oder Dokumentationen und Daten während des gesamten Produktentwicklungslebenszyklus vom Konzept zur Vermarktung anlegen.