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Dossplorer regulatory dossier viewer
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Quality Assurance
Leveraging Quality by Design
Qdossier commits to do things right first time. This is embodied in our culture, processes and the tools we use. Complex processes are not assured by verification of the end result, but embedded as Quality by design.
People
Our staff come from diverse backgrounds, experience and personalities, but all share the same high standards when it comes to quality of Qdossier deliverables. This combination ensures that our people bring value up to and beyond our customer’s expectations. Through our training process, we ensure every employee is sufficiently trained before they take on their tasks. This way, we safeguard our customer’s assets resulting in consistent, high quality deliverables. Knowing the context of these processes, our team recognizes potential risks beyond their core responsibilities.
Process
Qdossier processes have been developed to assure quality by design and efficient controls. As a result, the controls are related to the quality of the input received, the validation of intermediate steps and end result. These processes are governed by our internal Quality Management System (QMS). There is a dedicated Quality systems manager, ensuring focus on control and continuous improvement. We continuously review and improve our processes to ensure we can deliver high quality while maintaining flexibility and speed.
We offer the flexibility to adapt to customer defined processes, where needed. A document control process is in place to ensure changes are implemented in a controlled manner. Impact to other processes and activities is assessed and appropriate action are taken. Our team will proactively work with the customer to come to the best possible solution in case quality is potentially at risk.
Tools
Qdossier offers a validated hosted submission management platform to facilitate our services. In addition, the development, release and operational activities for Qdossier’s Dossplorer™ are governed by our QMS.
Procedural documents are reviewed at least once a year to ensure they remain aligned with current best practice and business needs. Thanks to short communication lines and a dedicated Quality systems manager, processes can be continuously reviewed and updated to include and embrace new best practices and lessons learned across Qdossier.
