trialwiseSCAN is a 21 CFR part 11 compliant, validated mobile document scanning application that delivers on-device indexing and direct eTMF transfer to maximize operational efficiency and enhance TMF quality.
Improve TMF Contemporaneity
Streamline the flow of high quality documents into your eTMF.
Improve TMF Completeness
Reduce the risk of lost and misfiled documents with robust, validated processes that drive correctly indexed documents to the appropriate location in your eTMF.
Deliver Improved TMF Quality
Take your TMF quality to the next level and stay inspection ready with improved contemporaneity, completeness and clarity.
21 CFR part 11 compliant
Meet compliance obligations for robust, validated processes. See our 21 CFR Part 11 Compliance Checklist for details of the controls used to maintain compliance.
trialwiseSCAN is internally validated for reliability, consistency and accuracy against established requirements. Refer to our whitepaper for details.
Archive ready PDF/A
Deliver PDFs that conform to ISO 19005 standard PDF-A-1b, the recommended standard for long term, reliable reproduction of document visual appearance. See our PDF/A whitepaper for details.
Automate filename generation
Promote consistency and minimize manual re-entry and errors, by enabling the rapid application of structured filenames at an early stage in the document life cycle.
Control indexing standards & metadata
Implement indexing standards and deploy site level metadata according to study specific TMF requirements. See our whitepaper on file indexing for details.
Granular level controls
Manage sponsor and study specific requirements through configurable controls for image capture, indexing and file naming standards and metadata.