Document ID: URS-DESEQ2-001
Version: 1.0
Date: 2026-05-24
Author: Bhavitha Kandru
Status: Approved
This URS defines the user requirements for a DESeq2-based RNA-Seq differential expression analysis tool intended for use in research and pre-clinical development environments.
In scope: Statistical analysis of read count data to identify differentially expressed genes between two experimental conditions.
Out of scope: Read alignment, quantification, downstream pathway analysis, GxP production use without additional revalidation.
| ID | Requirement | Priority |
|---|---|---|
| URS-001 | The tool shall accept tab-separated gene count matrices as input. | Must |
| URS-002 | The tool shall accept a CSV sample sheet defining experimental conditions. | Must |
| URS-003 | The tool shall validate input file existence and structure before analysis. | Must |
| URS-004 | The tool shall reject inputs with missing required columns and produce a clear error message. | Must |
| URS-005 | The tool shall perform differential expression analysis using DESeq2 v1.42 or compatible. | Must |
| URS-006 | The tool shall produce a TSV results file containing gene_id, log2FoldChange, p-value, and adjusted p-value. | Must |
| URS-007 | The tool shall log software versions and timestamp with every run. | Must |
| URS-008 | The tool shall produce bit-identical outputs for identical inputs. | Must |
| URS-009 | The tool shall complete analysis of a 10-gene, 6-sample dataset in under 60 seconds. | Should |
| URS-010 | The tool shall preserve all input data without modification (data immutability). | Must |
- 21 CFR Part 11 — Electronic Records; Electronic Signatures
- GAMP 5 Second Edition — Risk-based approach to compliant computerized systems
- ICH Q9 — Quality Risk Management
| Role | Name | Date | Signature |
|---|---|---|---|
| Author | Bhavitha Kandru | 2026-05-24 | _____ |
| Reviewer | _____ | _____ | _____ |
| Approver (QA) | _____ | _____ | _____ |