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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Updated
May 25, 2026 - R
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alcoa-plus
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50 URS + 50 paired FS for GxP-regulated computer systems. CC-BY-SA 4.0. Synthetic, AI-authored, not a regulated record.
csv pharma data-integrity biotech gxp urs synthetic-dataset regulatory-compliance gamp5 eu-ai-act computer-system-validation 21-cfr-part-11 alcoa-plus functional-specification eu-gmp-annex-11
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Updated
May 16, 2026
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