Modernize Batch Records Without Replacing What Already Works

Batch Record Modernization Is Becoming a Manufacturing Priority

The FDA’s Quality Management System Regulation became effective February 2, 2026, incorporating ISO 13485:2016 by reference into 21 CFR Part 820. The whitepaper explains why the evolving regulatory environment makes completeness, attribution, traceability, and controlled production records increasingly important to manufacturing as well as Quality.

At the same time, manufacturers are under pressure to:

• Improve release predictability
• Reduce avoidable review effort
• Standardize execution across products, lines, shifts, and sites
• Scale without proportional increases in review workload
• Maintain control without creating unnecessary disruption to existing infrastructure

A device can finish manufacturing on time while its Device History Record/Batch Record is still days away from release readiness.

Quality teams may still need to locate records, verify signatures, reconcile corrections, investigate exceptions, and reconstruct what happened across disconnected systems.

The issue is not necessarily poor manufacturing performance. And it may not mean you need another system of record.

The problem may be the execution gap between the systems you already have. 

This whitepaper explores a different approach to batch record modernization: adding controlled execution between ERP, PLM or document management, and quality systems, so evidence is captured as work happens and a review-ready record becomes an outcome of production rather than a reconstruction after it.

Where Is Your Execution Gap?

Ask yourself:

• Do quality reviewers still reconstruct production records after manufacturing is complete?
• Are signatures, corrections, measurements, and exceptions captured across multiple systems or manual supplements?
• Can you confirm that operators used the correct approved instruction at every controlled step?
• Are qualification, equipment readiness, material identity, and required parameters verified before work proceeds?
• Are deviations connected to the exact production context in which they occurred?
• Does the completed DHR arrive review-ready, or does Quality still have work to do before release?
• Would modernizing execution require disrupting ERP, PLM, QMS, or other systems your operation already depends on?

If production completion and release readiness are still two different milestones, there may be an execution gap between them.

What You’ll Learn

A Practical Framework for Closing the Execution Gap

Why Existing Systems May Still Leave a Gap

Understand why ERP, PLM, document management, QMS, and even MES capabilities may each perform their intended roles while critical step-level production activity remains disconnected.

Why Modernization Does Not Have to Mean a Total Replacement

Explore how a controlled execution layer can complement the systems already governing production orders, specifications, quality processes, training, deviations, and CAPA.

The Five-Layer Controlled Execution Model

Learn the five capabilities that connect the approved process to governed execution and a review-ready record:

• Process Foundation
• Guided Operator Execution
• Real-Time Evidence Capture
• Quality Connection
• Release Readiness

How to Make Review by Exception Practical

See how contextual evidence, attributed corrections, linked deviations, and flagged parameters can help Quality focus review where attention is actually required.

What to Evaluate Before Choosing an EBR Approach

Get practical recommendations for mapping the execution gap, defining what “review-ready” means, assessing coexistence with your existing technology landscape, and planning adoption before scaling.

You May Not Need to Replace More Systems.

You May Need to Connect What Happens Between Them.

ERP can know the production order.
PLM can hold the approved specification.
QMS can manage the deviation.

But who governs what happens during execution, step by step?

The whitepaper introduces a controlled execution model for connecting these systems while preserving their existing roles and creating a complete, attributed, review-ready Device History Record/Batch Record as work occurs.

Close the Gap Between Production and Release Readiness

Download How Medical Device Manufacturers Can Modernize Batch Records Without Disrupting What Works to explore the Controlled Execution Layer Model and a practical approach to modernizing batch records around the systems your organization already depends on.