Operations · BatchReleaseIQ

Product Disposition & Batch Release Checklist Software

The Fastest, Most Defensible Path from Production to Release — Built for Global Pharma

BatchReleaseIQ brings product genealogy, manufacturing information, testing results, market authorization, and hold information into a real-time batch release checklist — so Qualified Persons can make informed release decisions without manual paperwork and disconnected data collection.

Unify genealogy, manufacturing, testing, authorization, and holds in one checklist
Configure release workflows by product, site, and market
Give QPs a complete, traceable view for confident disposition
Surface release-ready and blocked batches in real time

Release Readiness Board

BatchReleaseIQ · Live Status

Connected

Release Ready

Blocked

In Review

Release-Ready Batches

BN-24081

Tablet Lot A · US / EU

Ready

BN-24074

Injectable B · JP

Ready

Blocked Batches

BN-24088

API Intermediate

LIMS result pending

BN-24091

Biologic Lot C

Hold review open

Batch BN-24088 · Release Checklist

Genealogy complete

MES / EBR closed

LIMS within spec

Market authorization

No open holds

ERPMES / EBRLIMSRIMSQMS

Real-Time

Batch Readiness

Connected

Enterprise Data

Configurable

Market Workflows

Audit-Ready

Traceability

Industry Challenges

Why Batch Release Still Takes Weeks — When It Should Take Hours

Manual collection across disconnected systems slows disposition, increases inventory pressure, and raises risk for Qualified Persons making release decisions.

Delayed Product Availability

Critical products may not become available when customers need them because release decisions can be delayed by incomplete information and manual follow-up.

Pending Inventory

Pending inventory can increase warehouse storage requirements, working capital exposure, and product aging while batches wait for disposition.

Manual Data Collection

Qualified Persons may need to manually collect information from multiple enterprise systems before a release decision can be made.

Fragmented Release Information

Important data may be distributed across ERP, MES / EBR, LIMS, RIMS, and QMS — making a complete release view difficult to assemble.

Inconsistent Market Requirements

Different markets may have different release and sign-off requirements, adding complexity to multi-market disposition workflows.

Third-Party Data Visibility

Contract manufacturing and outsourced testing information may not be immediately available during release review.

Release Decision Risk

The batch release decision is a high-stakes quality decision requiring complete and traceable information before sign-off.

SOLUTION OVERVIEW

One Source of Truth, Built From Data You Already Have

BatchReleaseIQ connects existing enterprise information instead of requiring duplicate manual data entry — assembling a real-time disposition checklist from systems you already run.

ERP

Component and supplier status and product genealogy that inform disposition readiness.

MES / EBR

Equipment settings, in-process checks, and manufacturing testing information for each batch.

LIMS

Test results and conformity to specification needed for quality disposition.

RIMS

Market and sales approval status, application changes, and regulatory commitments.

QMS

Non-conformances, OOS results, CAPA status, and change control affecting release.

CAPABILITIES

Real-Time Batch Release Intelligence

Configure market-aware checklists, monitor release readiness, and give Qualified Persons a complete, auditable view of every batch.

Real-Time Release Readiness

Identify when a batch meets its release criteria as enterprise data updates.

Configurable Batch Release Checklists

Configure release workflows based on product, site, and market requirements.

Full Batch Genealogy

Bring component, supplier, manufacturing, testing, authorization, and hold information together.

Event-Driven Readiness Alerts

Notify relevant users when outstanding release criteria are completed.

Live Release-Readiness Board

Provide visibility into release-ready batches, blocked batches, blocking conditions, and priority batches.

Third-Party Data Visibility

Bring contract manufacturing and outsourced testing data into the same review workflow.

Streaming Audit Trail

Capture data pulls, reviews, actions, and electronic signatures for inspection readiness.

Market-Aware Workflows

Support market-specific release requirements without requiring custom code.

REAL-TIME CONNECTIVITY

How Real-Time Connectivity Actually Works

Enterprise systems feed BatchReleaseIQ through live integration so release readiness stays current for QP review and disposition.

Enterprise Systems

Data Integration

BatchReleaseIQ

Release Readiness

QP Review

Release Decision

ERPMES / EBRLIMSRIMSQMS

Live API Connections

Connect enterprise systems so disposition data stays current.

Event-Driven Updates

Refresh readiness as manufacturing, testing, and quality events complete.

Release Readiness Alerts

Notify teams when criteria clear and batches become reviewable.

Live Batch Status

Track release-ready, blocked, and priority batches in one board.

Third-Party Data

Include CDMO and outsourced testing status in the same checklist.

Audit Trail

Preserve a streaming record of pulls, reviews, and e-signatures.

BATCH RELEASE WORKFLOW

From Production Completion to Confident Release

A controlled path from batch data availability through QP review to the configured release decision.

Batch Data Available

Manufacturing and batch information becomes available for disposition review.

Quality Data Connected

Testing, quality events, and relevant enterprise data are brought together.

Release Criteria Evaluated

Configured release criteria are checked against the connected batch record.

Outstanding Items Identified

Blocked or incomplete criteria are clearly displayed for action.

QP Review

Qualified Person / QCU reviews the complete batch information in one place.

Release Decision

The batch can proceed through the configured release workflow with confidence.

BUILT FOR YOUR TEAMS

Built Around the People Who Actually Make the Release Decision

BatchReleaseIQ supports Qualified Persons, quality, operations, and leadership with the visibility each role needs.

Qualified Person / QCU

Complete release information with an auto-populated checklist spanning genealogy, manufacturing, testing, market authorization, and holds.

Complete release information
Auto-populated checklist
Batch genealogy
Manufacturing & testing data
Market authorization & holds

Quality Management

Controlled workflows with audit trail, electronic signatures, sign-off sequencing, and geography-aware release processes.

Controlled workflows
Audit trail
Electronic signatures
Sign-off sequencing
Geography-aware workflows

Operations Management

Visibility into release-ready and blocked batches, priorities, shipping readiness, and holding status.

Release-ready batches
Blocked batches
Priorities
Shipping readiness
Holding visibility

Executive Leadership

Insight into release cycle time, risk exposure, bottlenecks, and multi-site / multi-market visibility.

Release cycle time
Risk exposure
Bottlenecks
Multi-site visibility
Market visibility

SAME DATA, DIFFERENT DECISIONS

Same Data, Different Decisions

BatchReleaseIQ, APQR, and CPV share a quality data foundation — each optimized for a different decision.

Area	BatchReleaseIQ	APQR	CPV
Primary Purpose	Batch release / disposition	Product quality review	Process monitoring
Timeframe	Per production run	Defined review period	Rolling monitoring
Data Perspective	Real-time batch readiness	Retrospective product review	Near-real-time process behavior
Primary Users	Operations / QP / Quality	QA / Quality Management	Process / Quality Leadership
Outcome	Release or hold decision	Product quality assessment	Process control and trend detection

Primary Purpose

BatchReleaseIQ

Batch release / disposition

APQR

Product quality review

CPV

Process monitoring

Timeframe

BatchReleaseIQ

Per production run

APQR

Defined review period

CPV

Rolling monitoring

Data Perspective

BatchReleaseIQ

Real-time batch readiness

APQR

Retrospective product review

CPV

Near-real-time process behavior

Primary Users

BatchReleaseIQ

Operations / QP / Quality

APQR

QA / Quality Management

CPV

Process / Quality Leadership

Outcome

BatchReleaseIQ

Release or hold decision

APQR

Product quality assessment

CPV

Process control and trend detection

WHAT YOU GET

What You Get

Operational release intelligence designed for regulated disposition — not another retrospective report.

Real-Time Readiness

A per-batch health check rather than a retrospective report.

Configurable Market-Aware Checklists

Workflows configured by product, site, and market.

Full Genealogy in One View

Complete batch-related information in one place for disposition.

Third-Party Manufacturing Visibility

External manufacturing and testing data within the release workflow.

Audit-Ready by Design

Traceable actions, reviews, and electronic signatures.

Foundation for APQR and CPV

Connect batch disposition data with longer-term quality and process monitoring.

ADVANCED OPERATIONS INTELLIGENCE

Turn Batch Data Into Release Intelligence

Operational visibility for readiness, bottlenecks, holds, priorities, and multi-site release status — without unsupported AI or predictive claims.

Batch Readiness Monitoring

Track when batches meet configured release criteria across sites.

Release Bottleneck Identification

See where outstanding criteria slow disposition decisions.

Pending Batch Visibility

Monitor batches awaiting data, review, or sign-off.

Hold Tracking

Keep hold information visible alongside release readiness.

Release Priority Management

Surface priority batches so teams focus on what matters first.

Cross-Site Release Visibility

Compare release status across manufacturing sites in one view.

Market-Specific Release Status

Understand disposition progress against market requirements.

Quality Event Visibility

Keep non-conformances, OOS, and CAPA context in the release path.

CONNECTED QUALITY ECOSYSTEM

Connected to the Systems That Power Your Release Decision

Each connected system contributes specific disposition context — genealogy, manufacturing, testing, authorization, and quality events.

ERP

Component and supplier status and product genealogy that inform disposition readiness.

MES / EBR

Equipment settings, in-process checks, and manufacturing testing information for each batch.

LIMS

Test results and conformity to specification needed for quality disposition.

RIMS

Market and sales approval status, application changes, and regulatory commitments.

QMS

Non-conformances, OOS results, CAPA status, and change control affecting release.

COMPLIANCE

Built for Regulated GxP Operations

Platform capabilities that support regulated disposition workflows and validation documentation — without implying unsupported certifications.

GAMP 5

Designed to support GAMP 5 expectations for computerized systems in regulated operations.

21 CFR Part 11

Supports electronic records and signature controls aligned with Part 11 expectations.

EU GMP Annex 11

Supports Annex 11-oriented controls for computerized systems in GxP environments.

ALCOA+

Helps preserve attributable, contemporaneous, and complete disposition records.

CSV Validation Documentation

Supports computer system validation documentation for regulated deployments.

IQ / OQ / PQ

Supports qualification documentation pathways for installation, operation, and performance.

RTM

Supports requirements traceability matrix documentation for validated workflows.

WHY AMPLELOGIC

Why Global Pharma Manufacturers Choose AmpleLogic

A low-code, GxP-native platform built for multi-site disposition and connected quality operations.

Low-Code, GxP-Native Platform

Configure disposition workflows according to SOPs and regional requirements without brittle custom code.

Validated for Regulated Use

Support regulated workflows and validation documentation expected in life-sciences operations.

Multi-Site, Multi-Market Operations

Support different release requirements across sites and markets from one platform.

Connected Quality Ecosystem

Connect BatchReleaseIQ with APQR and CPV through a common data foundation.

INDUSTRIES

Built for Global Life Sciences Operations

Designed for pharmaceutical, biotech, CDMO, API, and broader life-sciences manufacturing networks.

Pharmaceutical Manufacturing

Support batch disposition across finished-dose manufacturing and quality release operations.

Biotech & Biologics

Bring complex manufacturing and testing context into a controlled release checklist.

Contract Manufacturing / CDMO

Improve visibility into third-party manufacturing and testing data during release review.

API Manufacturing

Connect genealogy, manufacturing, and quality information for API batch disposition.

Life Sciences

Extend disposition workflows across regulated life-sciences manufacturing networks.

From Weeks of Chasing Data to Hours of Confident Release

BatchReleaseIQ gives Qualified Persons the information needed for a controlled batch release decision — without relying on manual spreadsheet collection and disconnected systems.