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Quality for Oracle Process Manufacturing

AGSS Process Manufacturing Sales Support Team

Agenda
General concepts Process Quality Solution
Key Functionality

Additional resources

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General Concepts

Manufacturing Building Blocks

Analysis Costing

Product Development

Planning

Purchase

Produce

Order Management

Quality Inventory

Quality Management
Analysis Costing

Product Development

Planning

Purchase

Produce

Order Management

Quality Inventory

Process Manufacturing Quality Flow

Quality Characteristics of Material
Receiving, In Process,
Shipping Inspection

Lot Expiration/Retest Environmental Monitoring

Material Usage Decisions Batch Adjustments Order Allocation

Standardize

Sample

Analyze

Disposition

Report

Tests and Methods Sampling Plans Specifications

Result Statistics Stability Studies

Certificate of Analysis Lot Genealogy

Process Improvement

WorkflowWorkflow-Driven Processes and Electronic Records

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Process Quality Solution

Process Quality Solution

Enables you to: Achieve product consistency Enforce proactive quality assurance Streamline quality lab productivity Assure customer and regulatory compliance

Key Functionality
Standardized inspection methodologies Stability studies Workflow driven quality management Customer specification matching at order Parent / Child lot traceability Certificate of Conformance and Analysis Quality driven lot usage decisions Expired lot management

Standardized Inspection Methodology

Quality Setup
Specification / Validity Rule Approval WF WF Sample Creation Notification Workflow WIP Sampling Information Composite Results

Specifications Definition

ERES

ERES Samples

WF

Creation

Testing Notification Workflow

WF

ERES Results Entry

& Evaluation

Item/Lot UOM WF Conversion

WF

Sample/Sample Group Disposition Approval, Sample Group Rejection

ERES

Stability Studies
Determine Product Shelf Life and Market Conditions
Stability study management:
Assess environmental aging effects on product quality Capture recommended shelf life and storage condition Support research and development activities Comply with FDA guidelines in regulated industries

Implementation methodology via workflow and project-oriented interface

Stability Samples

Batches

0 months 40C 75% relative humidity

3 months 40C 75% relative humidity

6 months 40C 75% relative humidity

Stability Studies
Measure the Effects of Environmental Aging
Base Monitoring Specification 0 1 3 6 9 12 18 24 months

0 1 23 Production Batch Stability Samples 0

months

Overlay Monitoring Specification (1)

Study Definition Sample Numbering Monitoring Specs Storage Conditions Storage Packaging Testing Intervals Item Specs

12

months

Overlay Monitoring Specification (n)

Work Flow Notices Lab Study Lab Study Execution Technician Owner Supervisor Ensure Timely Execution of All Data Points Assess Product Quality Over Time and Varying Environment Capture Recommended Shelf Life and Storage Condition Support Research and Development Activities Comply With FDA Guidelines in Regulated Industries

Pre-Defined Quality Workflows

Check Quality Throughout the Supply Chain

Receiving

Inventory

Shipping

Suppliers


Production

Customers

Automatic Workflow Notifications at Each Quality Check Point for:

 Quality check points

Sample Creation Assay Testing Sample Disposition Decision

Specifications Management
Unique Customer Specifications
Customer Specification Item Specification
Min

Out-of-Spec

In-Spec

Out-of-Spec

Match
Max

Define internal and customer products specifications Match available inventory to customer specifications Provide Certificate of Analysis (COA) with each
shipment

Global Traceability
Reduce Time to Resolve Issues
Lot Source

Supplier

Ingredients & Resources

Intermediate or Bulk Products

Finished Product

Customers

Where Used

Improve recall responsiveness / cost Comply with FDA, GMP, and other regulations Trace materials enterprise-wide to analyze supply chain quality

Certificate of Conformance or Analysis

Assure Product Quality Through Documentation Certify material for conformance to manufacturers or customers specification Print specification requirements and/or results Run separately or attach to shipment document set

Quality-Driven Lot Usage Decisions

Manage Ingredient Variability for Consistent Products

INVENTORY

QUALITY

AVAILABILITY

Shelf life Retest interval Potency Dual units of measure (UOM)

Sample lots Evaluate for

conformance to specification Accept or reject

Expiration date Lot status Grade Hold date Lot UOM conversions

Expired Lot Management

Validate and Manage Date-Sensitive Goods Notify when lots expire or require retesting Change expired lot status to prevent usage Manage retesting
Lot retest sample Lot retest tests from the specification

Process Quality Solution

Enables you to: Achieve product consistency
Stability studies, lot expiration management, process control points, quality throughout the supply chain

Enforce proactive quality assurance

Standardized inspection methodology, workflow, e-records and e-signature

Streamline quality lab productivity

Automated test/lab assignment, quality workbench

Assure customer and regulatory compliance

Customer spec matching, CofA / CofC, lot traceability

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Additional Resources

Additional Resources
Vivian Lewis AGSS SCM Solution Specialist
Vivian.Lewis@oracle.com Mobile 972-xxx-xxxx

Andrew Hyers AGSS SCM Solution Specialist

Andrew.hyers@oracle.com Mobile 502-xxx-xxxx

David Ballin AGSS SCM Solution Architect

David.ballin@oracle.com Mobile 201-218-3245 Office 201-794-6221