mo 16.15 track manufacturing john danese oracle

7/29/2019 MO 16.15 Track Manufacturing John Danese Oracle

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Life Sciences Supply Chain Management& Manufacturing Strategy

John Danese, CPIM

Life Science Strategy Director

Pharmaceutical & Biotechnology Industry Forum16-17 April 2007Mainz, Germany


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The following is intended to outline our general

product direction. It is intended for informationpurposes only, and may not be incorporated into

any contract. It is not a commitment to deliver any

material, code, or functionality, and should not be

relied upon in making purchasing decision. The

development, release, and timing of any features

or functionality described for Oracles products

remains at the sole discretion of Oracle.

Safe Harbor Statement


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Exciting Times for Life Sciences

Offering You the Gems of the Market

Acquisitions Just to name a few

PeopleSoft Top HCM

JD Edwards Production Scheduling (Numetrix), StrategicNetwork Optimization (SNO)

G-Log Transportation Management

Siebel Top CRM, Analytics, Clinical Trial Management

Demantra Demand Management #1 in Human Resource Management AMR Research The Human Capital Management Applications Report, 20052010 August 2006

#1 in Supply Chain Management The Supply Chain Management Spending Report, 20052006, AMR Research, Lora Cecere and Wendy Davis, July 2006

#1 in Customer Relationship Management IDC Market Analysis Worldwide CRM Applications

#1 in North America Business Applications AMR Research Report The Enterprise Resource Planning Report, 20042009November 2005


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Topics

Supply Chain Management Strategy

Manufacturing Strategy Regulatory Compliance


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Whats New for Process in R12?Key capabilities to support Pharma and Biotech Manufacturers

MES for Process Manufacturing

Dispensing

Comprehensive Electronic Batch Records Production Operator Workbench with process

instructions and SOP links

Nonconformance management

Device Integration

Labeling

E-Records Enhancements Enhanced auditing with relining

Additional approval methodologies

Streamlined approvals

Advanced Inventory Management for

Process Single inventory across the EBS

WMS for process industries

Advanced lot actions and genealogy (lot split,merge, translate)

Reduce risk by

Minimizing data redundancy

Reducing system complexity Ensure regulatory compliance by

Enforcing manufacturing best practices

Tracking all manufacturing actions in an electronicbatch record

Automating approvals

Increase speed of approvals

Improve collaboration

Simplify auditability of changes to critical data

Reduce Risk by providing a single source oftruth for inventory

Improve efficiencies with automated warehousetask management

Support postponement with better inventoryinformation

Features Benefits


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Supply ChainManagement Strategy


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Life Sciences SCM / Mfg Strategy

Enable Real Time S&OP

Provide integration of best-of-breed planning and analysis

capabilities with the operational execution capabilities of the

suite

Provide the broadest integrated drug development to

commercial manufacturing platform Provide the deepest in-suite manufacturing execution

capabilities of any top tier ERP

Build configurable compliance into the platform


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enabled by Key Investments

Demantra

Improve Demand Insights

Improve Forecast Accuracy

Assumption Based Forecasting

Collaborative Real-Time S&OP

Strategic Network Optimization (Numetrix)

Visualize supply network in advance of new product launches

Simulate impacts of changes to supply network

Acquisitions; add/remove DCs, plants

Contingency planning for unplanned events, such as cost

changes, natural disasters, transportation or communication

line

integrated with the suite


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Demand Driven leaders have:

15% less inventory

17% stronger order fulfillment 35% shorter cash-to-cash cycle times

Which translates to:

60% better profit margins

65% better EPS

2-3X the ROA

0

50

100

150

200

250

300

350

Strong Weak

Perfect Order Inventory

Cash-to-Cash SCM Costs

Source: AMR Benchmark Analytix

Why Is S&OP Important?

Tangible benefits!


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Why is S&OP Important in Pharma?

Push Mode is Inefficient and Costly

92%

3X more output30%Equipment Utilization

75% - 85%20% - 65%Demand ForecastAccuracy

99.6%60% - 80%On Time Full Delivery

50

$91B

3 to 5Stock Turns

World Class FactoryPharma IndustryMeasure

Source: R. S. Benson and D. J. MacCabe. From Good Manufacturing Practice to GoodManufacturing Performance Pharmaceutical Engineering. July/August 2004.

Source: AMR Benchmark Analytix


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Execute

Demand Planning Supply Planning S&OP Meeting

Market Demand

ForecastingMarket Demand

Forecasting

New Product

ForecastingNew Product

Forecasting

Promotion PlanningPromotion Planning

Consensus

ForecastConsensusForecast

Safety Stock DemandInventory

OptimizationInventory

Optimization

Constraint-BasedProductionScheduling

Strategic NetworkOptimization

Evaluate Supply

ConstraintsEvaluate Supply

Constraints

Measure Financial and Customer Service Level Results

S&OP Outputs:Service levels

Profitability

Inventory LevelsPromotions

DRP

MPS

S&OP Outputs:Service levels

Profitability

Inventory LevelsPromotions

DRP

MPS

S&OP ReviewS&OP Review

Oracle Closed Loop S&OP Planning

DemandData


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Real Time S&OP

Compresses the Planning Cycle, Plan with Current Information

Day 1 Day 30

Collect Demand

Review, Edit & ApproveDemand Plan

ConstrainedSupply Plan

Review, Edit &Approve Supply Plan

S&OP Meeting Publish Plan

Typical S&OP Process

Inefficient consensus process, enabled withdisconnected spreadsheets

Day 1 Day 30

Collect Demand


Constrained

Supply Plan



Real Time S&OP Process

Automated approval process with role-basedconsensus process enables agility to respond

to changes


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Real Time S&OP


Day 1 Day 30

Collect Demand






Publish Plan

Day 1 Day 30

Collect Demand


Constrained

Supply Plan


S&OP Meeting


Manufacturingdisruption

Distributordraws downinventories

Flu outbreakin Texas


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Real Time S&OP


Day 1 Day 30

Collect Demand







Manufacturingdisruption

Distributordraws downinventories

Day 1 Day 30

Collect Demand

Review, Edit &Approve Demand

Plan

Constrained

Supply Plan Publish Plan

Review, Edit &Approve Supply

Plan

Review, Edit &Approve Demand

Plan

Constrained

Supply Plan

Review, Edit &Approve Supply

Plan

Collect Demand

Automation enables flexibility torespond within the planning cycle

Flu outbreakin Texas


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Business Process Integration Plan

Demand Planning

Demantra Demand Management

Demantra Advanced Forecasting

Strategic Network Optimization

Inventory Optimization

Adv. Supply Chain Planning

Supply Planning

CRM

SRM

Supplier Contracts

SCM

Finance

Financial Planning and Budgeting

Sales and Marketing

Sales

Marketing

Trade Promotion Planning

Demantra Predictive Planning

Demantra Promotion Optimization

Demantra Deduction & Settlement

Sales

and

Operations

Planning

Supply Chain Execution

Manufacturing

Order Management

Shipping Execution

Logistics

Advanced Planning


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Back Office Front Office

Planning

Execution

TPMORT S&OP

DM

R/3

Enable Integrated S&OP in Heterogeneous

Environments

Demand DrivenBusiness Solutions

APO


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Manufacturing ExecutionStrategy


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R12.1

Post 12.1

The MES Spectrum

Volume andAutomation

Complexity

(Compliance,

Tracking, etc)

Niche MESPlayers

OracleManufacturing

ExecutionSystem R12

Shift Hour Minute Second


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Plant to Enterprise Strategy

OPM + MES forProcess

Process Instructions & SOPs,Dispensing, Nonconformance Mgmt.,

Electronic MBR and CBR, Mobile,Labeling, Device Integration

OPM

MES for Process

Devices

Electronic batch records, process-centric, low-med shop floor

automation, standardization anddata visibility across plants

Oracle Edge Server

OPM + integrationother MES

APIs and Web Servicesenable integration based on

S95

OPM

MES

Devices

Electronic batch records,decentralized plants, highlyautomated, accept costs ofmaintenance of integration

Web Services

3rd Party Integration

OPM

Existing ProcessManufacturing Suite

OPM

Paper batch records,material-centric, minimalautomation and manual

data entry

Offering Choices for Various Manufacturing Needs


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Oracle MES for Process Manufacturing

Process Flow SummaryRoles

ProcessEngineer/Formulator

Manages recipes andadvanced processinstructions

Production Supervisor

Creates and manages batchstatus

Logs nonconformances

Dispensing

Pre-weighs designatedingredients

Production Operator

Processes batch operations

ProductionOperator

ProcessEngineer

ProductionSupervisor

DispensingOperator

Create Recipe

Add New EnhancedProcess Instructions

Create/UpdateValidity Rule

& ReviewMaster Batch Record

Schedule Batch& Reserve Materials

DispenseIngredients

Lock Operation,

Follow PI,Execute Tasks

ReverseDispense

Ingredients

Complete &Close Batch

Log

Nonconformances

Review ControlBatch Record


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UI Tester for R12+ MES Interface


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Operator Workbench R12.1Touch Screen Enabled

Links to SOPs

Online ProcessInstructions

One-touch access tokey transactions


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Complete Process Support for Work Instruction Display, Dispensing,Batch Progress Tracking, and Ingredient Consumption Reporting

Supporting DeepManufacturingOperationsManagement

Process guides move

operators through

work instruction view,

progress reporting,

and material

consumption tracking

Quality data collection

and lot data

capture for genealogy

Integration to process

equipment

Dispensing R12.1

Touch Screen Enabled


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When Best of Breed MES is NeededOracle S95 Approach

B2MML Standard Messaging

O r a c le F u s i o n M id d l e w a r e

O P MC r e a t e B a t c h

M E S

C o m p l e teB a t c h

Production

Schedule

B2MML

Product io

n

Comple

tion

B2MM

L

Re

co

rdAc

tua

l

Mat e

r ial

&

Res

ou

rce

Con

su

mpti o

ns

BatchInformation-

Material&

Resource

Requirements

O r a c le E n t e rp r is e S e r v ic e B u sO r a c le E n t e rp r is e S e r v ic e B u sO r a c le E n t e rp r is e S e r v ic e B u sO r a c le E n t e rp r is e S e r v ic e B u s

B A M

A d a p te r sB 2 B B P EL P MS e c ur ity

R o utin gT ra n sf o rm at io nM e ssa g in g

O r a c le E n t e rp r is e S e r v ic e B u sO r a c le E n t e rp r is e S e r v ic e B u sO r a c le E n t e rp r is e S e r v ic e B u sO r a c le E n t e rp r is e S e r v ic e B u s

B A M

A d a p te r sB 2 B B P EL P MS e c ur ity

R o utin gR o utin gT ra n sf o rm at io nT ra n sf o rm at io nM e ssa g in gM e ssa g in g

Enabled with Fusion Middleware

Oracle Objectspre-mapped to

S95 Entities


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Schedule Data

Released WO

Released Batches

Rel. Flow Sch. Prodn. ActualsCompletions

Scrap

Main. Notifications

Resource Charges

MES Data

Actual Times

WIP Transactions

Quality ActualsSchedule Data

Wo/Schedule to MES

M/C Download

Device Data

Actual Counts

Actual Times

Parameter Values

Actual Scrap

Equipment Status

Master Data

Item Master Subset

Item Costs

Resource Costs

EMI Solution Architecture

Corporate ERP

Corporate

EMI Dashboards

Plant Specific KPIsReal-time KPIs

MES

Automation & Control

Historian

PLC

SCADA

Transactional Systems

MES

LIMS

Legacy

Quality

SPC/SQC

CMMS

S-95

EMI Hub

OEE

SPC/SQC

Schedule Adherence

Agility-cycle times

Productivity

Batch Analyzer

DBI

Plant


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ePedigree Solution Architecture

Provides the tools

necessary for dataconsolidation and

integration

Facilitates sophisticated

data manipulation,

analysis, and reporting

Enables better

interpretation of data

Supports pedigree

reporting across the supplychain

Oracles Information Driven Supply Chain


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Drive Operational Excellence

Enable Regulatory Compliance

Manage Supply Chain Risk

Get Richer Information. Make Faster Decisions. Deliver Better Results.

Oracles Information-Driven Supply ChainManagement Offering Enables You to


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mo 16.15 track manufacturing john danese oracle

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