Streamlined Systematic Literature Reviews

CAPTIS™ is a ground-breaking solution for the RA/QA departments in the medical device industry looking to increase compliance and reduce the burden on their resources.

Celegence’s CAPTIS™ software solution simplifies the process of writing PMS documentation for EU MDR and IVDR compliance. It allows medical writers to conduct systematic literature reviews by screening and assessing literature in a streamlined way. Both Celegence and industry medical writers have noticed over 20% increase in productivity when using this innovative solution, as it seamlessly integrates with literature and adverse event databases to automate the creation of post market surveillance documentation such as Clinical Evaluation Reports and Post Market Safety Reports.

Celegence’s new CAPTIS™ MDR/IVDR solution has helped medical writers write 100s of CERs and PERs with more ease and confidence than ever before. It is designed from the ground up to give you a better review experience, faster project completion and transparent, audit-ready results.

• Support for document lifecycle management
• Improved collaboration via cloud integration
• Predefined reports, which can be generated by specific user role
• Integration with literature databases with simple article management
• Automation for activities like data consolidation and formatting
• Integration with the TPLC database for PMS information

CAPTIS™ offers medical writing teams a solution to improve their collaborative efforts needed for compliance. A sleek interface and time-saving workflows with literature database integrations such as PubMed and Google Scholar are not the only objectives of the platform: we also prioritized improved compliance and reproducibility of data. Notified Bodies expect that the data reflected in CEPs and CERs is both traceable and reproducible, and this is not always the case if a manual process is utilized to screen literature data. When Notified Body reviewers see that a solution like CAPTIS™ has been used to screen literature, their confidence in the data increases significantly and they are able to approve documents more quickly. Of course having uniform processes across various medical writers is critical in ensuring accuracy.

Collaboration features in CAPTIS™ allow writers and reviewers to directly tag team members and highlight and tag relevant portions. Cross-functional teams can work simultaneously on the same report to make sure it is reviewed by the right stakeholders and completed on time.

Performing systematic literature reviews (SLR) is an arduous and time-consuming process that involves not only comprehensive literature searching but also record de-duplication, title/abstract and full-text screening, data extraction, quality assessment, statistical analysis, data visualization, report writing, and the creation of a bibliography. Here, we compile a comprehensive list of features of CAPTIS™ in comparison to other solutions in the market.

With functionality beyond literature review support, CAPTIS™ successfully decreases the turnaround time of the required documentation with features such as document lifecycle management, source document management and improved collaboration between medical writers, Subject Matter Experts, and clients.

An overview of this innovative platform is available here: https://www.celegence.com/mdr-compliance-technology-captis/

Improving the efficiency and management of your MDR and IVDR documentation is the core objective of CAPTIS™. This video offers a glimpse into the features and capabilities offered by this innovative software platform.

Due to demand and interest from the industry, we have devised an easy onboarding process for new clients migrating away from other solutions to CAPTIS™.

To learn more and view a comprehensive demo of CAPTIS™, reach out to info@celegence.com  today or contact us online to connect with a Celegence representative.