AI-assisted Quality Management System (QMS) for automated complaint intake, 21 CFR Part 211 / Part 11 compliance, FDA 15-Day FAR risk assessment, and PDF generation.
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Jul 29, 2026 - Python
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21cfrpart11
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Excel-Based LIMS Development and Computer System Validation (CSV) project Following GAMP 5,
csv validation lims pharma dataintegrity gamp5 computer-system-validation 21cfrpart11 iq-oq-pq euannex11 excel-vali validation-summary-report
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Jun 22, 2026
Validated DESeq2 RNA-Seq pipeline with full CSV lifecycle (URS, IQ/OQ/PQ), 21 CFR Part 11 and ALCOA+ compliance mappings, and GAMP 5 documentation.
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May 25, 2026 - R
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