A Quality Leader's Guide to Review by Exception
/ Scaling Quality Oversight

A Quality Leader's Guide to Review by Exception

A Quality Leader's Guide to Review by Exception
  • Achieve Right-First-Time rates exceeding 90% through automated verification.
  • Scale manufacturing capacity without a linear increase in Quality headcount.
  • Compress batch review cycle times from weeks to hours.

Map your path to faster batch reviews

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Key Takeaways

With Mareana, you can transform unstructured manufacturing data into a compliant, algorithmic review process that accelerates batch release and reduces operational risk.

In this whitepaper, you will learn

  • Strategic frameworks for matching a digital pathway to your specific organizational maturity and operating model.

  • Key Performance Indicators (KPIs) to measure batch release maturity and demonstrate continuous improvement to regulators.

  • Practical approaches for extracting structured, queryable data from "dark" sources like scanned PDFs and paper logs.

  • How recent regulatory updates to EU GMP Annex 11 and FDA QMM are mandating a shift toward Review by Exception.

Good Manufacturing
Practice

Connected Data Deep Insights.

Good Manufacturing
Practice

Connected Data Deep Insights.

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Frequently Asked Questions

Review by Exception (RbE) is a quality review methodology where QA teams focus only on deviations, anomalies, and critical exceptions instead of manually reviewing every batch record entry. It helps improve compliance, reduce review time, and accelerate batch release.

Review by Exception uses automated validation rules and digital workflows to identify only problematic data points. This reduces manual review workload, shortens batch disposition timelines, and allows faster product release without compromising quality or regulatory compliance.

Regulatory agencies like the FDA and EMA are encouraging risk-based and automated quality oversight. Review by Exception supports compliance with EU GMP Annex 11, 21 CFR Part 11, ALCOA++ data integrity principles, and FDA Quality Management Maturity (QMM) expectations.

Automated batch review systems help pharmaceutical manufacturers:

  • Reduce documentation errors
  • Improve data integrity
  • Accelerate batch release
  • Increase QA productivity
  • Strengthen audit readiness
  • Minimize compliance risks

These systems also improve operational efficiency across manufacturing sites and CDMOs.

Electronic Batch Records (EBR) digitize manufacturing documentation, while Review by Exception is a review methodology that automatically flags deviations and exceptions for QA review. EBR systems often enable Review by Exception capabilities through structured digital data.

8 AI use cases to transform your quality assurance.
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8 AI use cases to transform your quality assurance.

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