Biopharma Quality Efficiency

Refined by Review by Exception

What is Review by Exception?

From exhaustive review → to intelligent, exception-focused QC

Instead of manually checking every data point, Review by Exception focuses expert time on:

Unexpected or out-of-trend results
Deviations or signal anomalies
GMP-relevant events and changes requiring scrutiny

Outcome: Faster reviews, fewer errors, and stronger compliance

Why It Matters

50-60%

of analyst and reviewer time spent on manual data checks

$250M–$750M

annual value at risk across 500 batches

$500K+

cost per day from 5+ analyst-reviewer cycles delaying batch release

$10M–$50M+

potential cost from late findings post-release

Key Challenge: Reviews are highly subjective, leading to inconsistencies and missed events

Where Review by Exception Delivers Value

Audit Trail Review by Exception

Trigger-based log review for GMP-relevant changes
Automated detection of high-risk system events
Aligned with EU GMP Annex 11 & 21 CFR Part 11

Chromatogram Review by Exception

Covers 70–80% of QC assays (critical batch release and stability tests)
Auto-detects peak shifts, drift, and anomalies
Quantitatively compares to “golden batch”
Extensible to IR, MS, NMR, particle analysis, titration, and more assays

How Review by Exception Works

1. Data Integrity & Standardization

Structured, harmonized scientific data with metadata across instruments (e.g., different CDS), labs, and sites

2. Automation of Routine Checks

ML/AI-assisted anomaly detection with Subject Matter Expert (SME) oversight

3. Integrated Systems

Connected CDS, LIMS, ELN enabling context-aware review and issue resolution

Scalable Benefits

Efficiency

Major reductions in manual review and reprocessing, higher FTE capacity

Compliance

Consistent review logic, fewer missed events, stronger audit readiness

Batch Release

Near real-time issue detection and quick resolution = faster release and millions in recovered value

Why Start Now

Your Roadmap to Success

Start with high-burden workflows (chromatography assay & audit trail review are ideal starting points)
Build a harmonized scientific data foundation across QC
Expand Review by Exception across additional drug modalities and analytical assays (IR, MS, NMR, particle, etc.)

Explore resources

Learn how to transform your scientific data into AI-based outcomes.

Solution brief

Understand how to achieve digital QC

Read

Case study

Optimizing quality testing with LabWare and TetraScience

Read

Fact sheet

Transforming CGT quality testing to accelerate time to patient

Read

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Talk to an expert

By transforming how our scientists access, analyze, and share research data, we're unlocking new levels of productivity and enabling AI-powered insights through a connected, online data environment. Beyond boosting productivity, we're leveraging data and agentic AI to accelerate innovation across our drug discovery engine.

Jim Villa
Global Head of Research Strategy & Operations

Our expanded partnership with TetraScience is delivering measurable value through unified access to instrument and CRO data that powers our automation and analytics at scale. The platform's audit capabilities have streamlined our regulatory preparation processes.

Linus Goerlitz
Regulatory Science Transformation Lead

Embedding AI and digital technologies across the R&D value chain is one of Takeda’s core strategic areas for our future. Our data-driven R&D approach will reduce discovery timelines, enable the identification of targets faster, and help us design better therapeutic candidates.

Nicole Glazer
Head of R&D Data, Digital and Technology