SMARTDECISIONS
SMARTVIGISCREEN is a cloud-based software solution that processes incoming ICSRs automating the analysis of company vs non-company cases and reducing screening workload by up to 70-80%.
Incoming batches of E2B(R3) format ICSRs from EudraVigilance database (for both L2A and MLM) are processed to extract all the data within and make this available in a variety of formats e.g. E2B(R3), E2B(R2) & readable HTML (all formats are available).
Features
- Intelligent text processing technology ensures quality by identifying potential cases with partial matches whilst safely excluding those which are not relevant for screening
- GxP validated system according to GAMP 5 guidelines and CFR Title 21 Part 11 compliant
- Audit trail with an audited screening process capturing all decisions made, the related exclusion criteria and company products
- Product configuration of SMARTVIGISCREEN is mirroring XEVMPD, hence XEVMPD needs to be up to date
Benefits
- Drastically reduces effort required in screening cases as well as load on the company’s PV safety database
- Intuitive, accessible, filtered and sorted display of all case data for efficient screening
- Automated triage of company cases with an intelligent text processing technology to exclude those not relevant to the MAH
- Export of full case processing reports and confirmed cases in readable format in XML
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