AI Risk Assessment: Medium Risk
85% ConfidencePredicted completion: 2024-12-10 • 27 days to deadline
Upload PK Mouse Study by Nov 25M4.2.2
Combine M2.6.4 and M2.6.5 reviewsM2
Module 3 ready for early validationM3
Progress
78%
Days Left
27
Documents
134
Issues
10
M1
AdministrativeAI
1
M2
CTD SummariesAI
2
M3
Quality (CMC)AI
M4
Non-Clinical
4
M5
Clinical
3
Recent Documents
QOS-Drug-Substance-Draft.pdf
2.3.SQuality Overall Summary - Drug Substance
Draftv1
AI Generated
92% confidence
AI
2.4 MBAI Generator•2 hours ago
Study-ABC-302-CSR.pdf
5.3.5Clinical Study Report
Approvedv2
JS
15.8 MBDr. Smith•Yesterday
Manufacturing-Process-v3.pdf
3.2.S.2.2Description of Manufacturing Process
In Reviewv3
ET
4.2 MBEmma Thompson•2 days ago
Owner
SC
Dr. Sarah Chen
Regulatory Affairs Director
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Recent Changes
v2.4Current
Added Clinical Study 302
John Smith • 2 hours ago
v2.3
Updated QOS formatting
Lisa Wang • Yesterday
v2.2
M3 validation passed
Dr. Sarah Chen • 3 days ago