For Clinical writing, the customer preferred to use Celegence templates, processes and CAPTIS technology, for preparation of Clinical documents. Celegence managed to gather inputs from various databases for sales, complaints, CAPA and other required data for creation of the documents.
For the technical remediation project, the customer chose to leverage Celegence’ s team of global regulatory experts to ensure compliance of their risk documents, testing plans and reports with EU MDR and latest version of the general and product specific standards. This project included devices with various risk classifications. The objective of the project was to execute the remediation plan and update required documents as per Customer templates and processes. Additionally, Celegence managed document change control process for approval in customer PLM system.