LabTrace AI — Functional Requirements Specification

PRODUCT: LabTrace AI is a cloud LIMS for pharmaceutical, cannabis, and environmental testing labs.

CORE WORKFLOWS:
1. Sample receipt → test assignment → data entry → result review → release/reject
2. OOS detection → Phase 1/2/3 investigation → CAPA → closure
3. Stability study setup → timepoint scheduling → result entry → trend analysis
4. SOP authoring → review → approval → effective date → periodic review
5. Equipment → calibration scheduling → maintenance tracking → OOS linkage

MASTER DATA SETUP RULES:
- test_method: Use ICH/USP/AOAC standard names. Examples by lab type:
    Pharma: "HPLC Potency", "GC Residual Solvents", "Karl Fischer Moisture", "Dissolution", "Particle Size by Laser Diffraction", "Microbial Limits", "pH", "Osmolality"
    Cannabis: "HPLC-DAD Potency (THC/CBD)", "GC-MS Terpene Profile", "LC-MS/MS Pesticides", "ICP-MS Heavy Metals", "qPCR Microbials", "GC-HS Residual Solvents", "Moisture by Loss on Drying"
    Environmental: "pH Measurement", "BOD5", "COD", "Turbidity (NTU)", "Total Suspended Solids", "ICP-OES Metals", "Fecal Coliform"
- analyst: Full names with credentials (e.g. "Dr. Sarah Chen, PhD", "Mike Torres, MSc")
- department: Functional lab departments (e.g. "QC Laboratory", "R&D", "Manufacturing", "Microbiology", "Regulatory Affairs")
- regulation: Applicable standards (e.g. "USP <621>", "ICH Q2(R1)", "21 CFR Part 211", "ISO 17025:2017", "EU GMP Annex 11")
- product_type: Sample classifications (e.g. "API", "Finished Product", "Raw Material", "In-Process", "Stability Sample")
- storage_condition: ICH standard conditions (e.g. "25°C/60%RH", "40°C/75%RH", "2-8°C", "-20°C", "Ambient")
- instrument_type: Equipment categories (e.g. "HPLC System", "GC System", "UV/Vis Spectrophotometer", "Karl Fischer Titrator", "pH Meter", "Analytical Balance", "Microscope")

AGENT TASK TYPES:
1. SETUP: Create master data from a lab description
2. SAMPLE_BATCH: Create multiple samples for a batch
3. STABILITY: Create a stability study with timepoints and assign test methods
4. REPORT: Summarize current OOS events and CAPA status
5. GENERAL: Answer questions about LabTrace data or perform any multi-step task

SUCCESS CRITERIA:
- All referenced master data exists before samples/studies reference it
- OOS events exist for all is_oos=true test results
- Stability studies have at least T0 and one future timepoint