Structured, Defensible Investigations for Pharma & Biotech Manufacturing
Every deviation needs a root cause. Every OOS needs an investigation. Your team shouldn't spend weeks producing what Lattice can structure in hours.
The Cost of Traditional Investigations
The Problem
- Operate under highly demanding regulatory and compliance requirements.
- Every deviation, OOS result, or malfunction triggers a formal investigation.
- Must produce a documented, defensible root cause with corrective actions.
The Impact
- A single site can generate hundreds of deviations annually.
- Teams spend weeks gathering batch records, logs, and environmental data.
- Causal analysis is rushed, resulting in investigations that don't prevent recurrence.
Lattice Root Cause
- Lattice natively structures your entire investigation from end-to-end.
- Auto-ingests batch records, logs, and quality data to evaluate hypotheses.
- Generates fault trees and produces comprehensive documentation automatically.
48% of FDA Warning Letters cite inadequate root cause investigation.
Between 2022 and 2025, nearly half of all FDA warning letters issued to life sciences manufacturers specifically highlighted failures in CAPA and RCA processes. Lattice helps you build an audit-ready, defensible investigation engine that scales.
Read the full RCA research report →Core Investigations
Systems designed to handle the highest stakes in the pharma & biotech industry.
Deviation Investigations
Systematic root cause analysis for process deviations, with full traceability from batch records through to corrective actions.
OOS / OOT Investigations
Investigate out-of-specification and out-of-trend laboratory results, connecting analytical data to process and materials factors.
CAPA Root Cause Investigations
Structured causal analysis for corrective and preventive actions, linking investigation findings to systemic process improvements.
Batch Failure Investigations
Investigate failed batches by connecting process parameters, raw material data, equipment history, and environmental monitoring records.
Supplier & Raw Material Investigations
Investigate incoming material deviations and their downstream impact on product quality, with linked supplier and internal evidence.
Equipment & Facility Investigations
Investigate equipment malfunctions, cleaning failures, and environmental excursions that could impact product quality.
Produce Investigations That
Hold Up Under Scrutiny
Lattice helps quality teams produce comprehensive, defensible investigations. Faster than manual methods and more rigorous than ad-hoc processes.