Prodigy Labs gives IND-stage biotechs, CROs, and CDMOs a single platform for 21 CFR Part 11 e-signatures, OOS investigations, CAPA, Document Control, and ISO 17025 QC — without the six-figure implementation cost.
Built for labs that operate under FDA and ISO quality frameworks. No bolt-on modules, no integration projects.
Experiment sign-off with legally binding electronic signatures. Second-witness enforcement for GMP experiments. Immutable audit trail with SHA-256 fingerprinting on every record change.
21 CFR Part 11Phase I and Phase II OOS investigation templates built to ICH Q10 and FDA OOS guidance. AI-drafts the Phase I narrative from your instrument data. Escalates to Phase II with full chain of custody.
FDA OOS GuidanceRoot cause analysis with 5-Why scaffolding. AI-assisted CAPA suggestions triggered from confirmed OOS investigations. Corrective + preventive action tracking with due-date enforcement.
ICH Q10SOPs, test methods, and quality agreements with full version history, review cycles, and approval workflows. Superseded versions archived automatically. Overdue review dashboard with email reminders.
ISO 17025 §8.3Draft → validated → approved → superseded method lifecycle with SST (system suitability test) result logging. Methods linked to experiments, OOS investigations, and CAPA records.
ISO 17025 §7.2Per-analyte Westgard rule monitoring with control charts. AI-powered result anomaly detection: ±2σ drift flagging, lot-change correlation, CV% trending. Direct path from warning to OOS investigation.
AI-AssistedGenerate standardized quality agreements from your org profile. ISO-compatible clause library covering scope, responsibilities, deviations, CAPA obligations, and audit rights. Controlled document from day one.
GMP-ReadyExperiment notebooks with voice-to-text capture, CSV data import, and PubMed cross-referencing. Every entry timestamped and immutable. AI analysis surfaces trends and anomalies across experiments.
Part 11 CompliantFEFO (First Expired, First Out) lot selection on every dispensing event. Full reagent lot history linked to sample results — so when an OOS fires, the correlated lot change is already in the record.
ISO 17025 §6.4Switch between ISO 17025, GMP, and multi-framework modes from your org settings. The platform adapts — required badges, OOS/CAPA enforcement, document review cadences, and Part 11 controls all activate automatically.
Accreditation-ready QC, method lifecycle, and document control. Default for analytical testing labs.
Part 11 e-signatures enforced. OOS and CAPA marked Required in sidebar. Document review cadences tightened. Audit trail on every mutation.
ISO 17025 + GMP simultaneously. Built for CROs and CDMOs serving both research and regulated manufacturing clients.
From the first anomalous result to a closed corrective action, every step is connected and traceable.
Westgard warning fires on the QC Dashboard. Result Trend chart shows ±2σ deviation with correlated lot change.
AI drafts the Phase I narrative from instrument data and analyte history. Analyst reviews and confirms.
Confirmed OOS escalates to Phase II root cause analysis. Full chain of custody maintained throughout.
AI suggests CAPA category, 5-Why starter, and corrective + preventive actions. Analyst edits and approves.
CAPA closed with linked OOS, method changes, and Part 11 signature. Audit-ready from day one.
"We needed OOS + CAPA before our FDA pre-IND meeting. Prodigy Labs had it live in a week — including the Part 11 audit trail our QA team required."
— QA Director, IND-Stage Biotech · San Diego, CA
Full SMS Biotech case study coming Q3 2026. Apply for early access to see a live demo with real GMP data.
Apply for access today. GMP mode activates immediately after onboarding. No implementation team, no 6-month timeline.
Application-gated access · No credit card to apply · 14-day trial available