gordon fleming evp & chief marketing officer life sciences update
TRANSCRIPT
Gordon FlemingEVP & Chief Marketing Officer
Life Sciences
Update
Regulatory Compliance
Life Sciences Manufacturers
Product Quality
Concerns
Patient Safety & Physician
Preference
New Product Developmen
t
Demanding Customer Requirements
Continuing Pricingand Margin Pressures
Global Consolidationand Alliances
Intense Shareholder Pressures
Wholesalers
Distributors
Group Purchasing Org
Government Programs
Evolving Regulatory Requirements
Life SciencesQuality
ValidationEnhancementCompliance
Validation
Quality
FunctionalitySerialization
Packaging & LabelsPotency & Formula
Enhanced Traceability
ComplianceFDA cGxP
FDA CFR 21 Part 11Cold Chain Management
QAD Proprietary
How We Define Needs and Priorities
QADCustomers
CompetitiveAnalysis
AnalystsResearch
IndustryStandards
INSIGHT™
QADPRC
Industry Roadmap
CustomerRequests
QAD Field Feedback
QAD SupportFeedback
Product Definition
ProductRoadmap
VerticalMarket
Collaborative Development
CustomerAdvisory Groups
Development Groups
Technical Foundation
QAD Strategic Steering Committee
QAD Product Review Committee
8
QAD Proprietary
9
AP
Credit
Packaging Line
Pick PackShip
Trade Compliance
Transportation
Sales & marketing
Invoice
AR
FeesRebates
Contracts
QAD Financials
CRM
TradeMgmt
DemandForecast Sales
Order
Configurator
Product Launch
PLM
Packaging
InventoryMgmt
WO /Repetitive
SSM
TMS
EDI Inbound
PO
ASN
MROPurchase EAM
Supplier ASN
EDI Outbound
Invoice
POSV
Medical Devices
ComplianceCompliance Module
Government
Enhanced Controls
EAM Validation TMS SSM
Manufacturing
Lean
QAD Serialization
QM Warehouse
WarehouseSV
QAD Serialization
EDI
EDI
ReturnsRecalls
Service Repair
DM APM
Customers: Distributors/Wholesalers
PLM
DM
APM
SV
TMS
SSM
EAM
Product Life Cycle Mgmt
Demand Mgmt
Advanced Pricing MedicalSupplier Visualization
Transportation Mgmt
Service & Support
Enterprise Asset Mgmt
Customer Relationship Mgmt
CRM
PIM
PIM Product Information Mgt
PIM
PIM
QAD Proprietary
AP
Credit
Packaging Line
Pick/Pack/Ship
Mixer
EAMReturnsRecalls
Trade Compliance
TransportationService
Sales & marketing Invoice
AR
Chargebacks
FeesRebates
Promotions
Contracts
QAD Financials
APM
CRM TradeMgmt
DemandForecast
DM
Sales Order
CSS
Product Launch
Engineering Change
Packaging
InventoryMgmt
Work Orders
SSM
TMSSerialization
EDI Inbound
PO
RxASN
MROPurchase
EAM
Supplier RxASN
EDI Outbound
Invoice
Customers:Distributor/wholesaler
Suppliers
PO
Process MFG
BioPharma Process Flow
Customers:Retailer/consumer/wholesalers
SV Warehouse
Serialization
Serialization
PLM
DM
APM
SV
TMS
SSM
EAM
Product Life Cycle Mgmt
Demand Mgmt
Advanced Pricing MedicalSupplier Visualization
Transportation Mgmt
Service & Support
Enterprise Asset Mgmt
Customer Relationship Mgmt
CRM
CSSCustomer Self Service
ComplianceCompliance Module
Government
Enhanced Controls
EAM Validation TMS SSMWarehouseQAD
Serialization
QAD Proprietary
11
Life Science Solutions Roadmap
cGMPCompliance
Lot TraceabilityValidation
ChargebacksDemand MgmtSales Analysis
CRF21 Part11Quality
Supply Visibility
PIMPLMEAM
TransportationExport
Serialization/ePedigreeCold Chain
QMS
Service & SupportCRM
Process MapsAnalytics
PotencyDual UOM
Catch WeightEnhanced Batch
New!QAD Enterprise Applications
2010
QAD Supply Visualization
Supply Chain PortalQuality Performance
Enterprise Asset Management 12
ComplianceFDA cGMP Maintenance
Audit compliance (TS, ISO, FDA, etc.)
Enterprise Asset Management 12
ComplianceEquipment Management
Machine Maintenance Execution
Test Equipment CalibrationReporting
Trade Management
2.8.2Browses
Collections
ProcessPotency
Batch BalancingFormulationTraceability
Product Recipe 1 Batch Qty = 3000 KG
Material Type ScalablePotency% Assay%
Tolerance % of BatchEffective
Qty Effective
UOMPhysical
Qty Physical
UOM
A1 Active Yes 80.00% +/- 10% 18.85% 540.00 KG 675.00 KG
E1 Excipient Yes 3.66% 105.00 KG 105.00 KG
E2 Excipient Yes 12.57% 360.00 KG 360.00 KG
E3 Excipient Yes 2.09% 60.00 KG 60.00 KG
S1 Standard Yes 41.88% 1200.00 KG 1200.00 KG
S2 Standard Yes 20.94% 600.00 KG 600.00 KG
F1 Standard No 1.00 EA 1.00 EA
Batch Total: 3000.00
Active Total: 540.00 675.00
Excipient Total: 525.00 525.00
Excipient Ratio: 0.2 | 0.686 | 0.114 0.2 | 0.686 | 0.114
Joint Development
AccelerateShare
Benefit
SerializationUnit Level
CA ePedigreeSafety
• Serial # range management • Aggregated serialized packaging
• Serial control unit/case/shipper/pallet• Label Printing• Serialized Pick/Pack/Ship• Event driven messaging & alerts• Audit trails• RxASN
Packaging LineProduct Serialization
EPCIS
Data Collection
Print Packer/Case/Pallet labels
Wholesaler EPCIS
Distributor EPCIS
Retailer EPCIS
RxASN
Wholesaler ERP
Distributor ERP
Retailer ERP
ePedigree
ePedigree
Pedigree Messaging
Serialized Inventory
Mgmt
Pick/Pack/Ship
QAD Serialization
RxASN
Supplier RxASN
QAD EA
Cold ChainTrack excursion timeCold chain material &
expirationAlert near expiration or expired
Expired or quarantine labelsTransfer inventoryScrap inventory
ValidationIn partnership with Strategic
ToolkitServices
Methodology
ProjectPlanning
CSVP
End User
Training
Modify User Procedures/Risk Assessment Test
Scripts
StandardBusinessScenarios
ReviewResults
ProcessModeling
UpdateSystemDesign
Reporting & System Extension Specification & Development - Minimal
Conversion Preparation and Testing
Prototyping/Fit to Business
Technical Infrastructure – IQ Execution Hardware & Software
Issue Resolution
Document Policy Issues
QualityAssuranceCheckpoint
Project Facilitation
Acceptance Testing
OQ/PQ Execution/Trace Matrix
Cut Over/Data
IQ
PostSupport
Software Validation Master Plan (SVMP) Development
Installation Qualification (IQ) Protocol(s) Development
Performance Qualification (PQ) Protocol(s) Development
Execution of Installation Qualification (IQ) Protocols
Execution of Operational Qualification (OQ) Protocols
Execution of Performance Qualification (PQ) Protocols
Baseline Configuration DevelopmentStress Test Procedure Development
Disaster Recovery Procedure DevelopmentFinal Validation Report Development21 CFR Part 11 Compliance Services
QualityIn partnership with Cebos
ISOcGxP
TS16949
Life Sciences EditionOn PremiseOn Demand
QualifiedSimplified Validation
Qualified Environment
LS Edition
• Global Delivery and Support• Quickly Add New Sites or New Users
• Additional Validation Environment Available• Flexible Upgrade Time Schedule
• Strictly Managed Operation Procedures• 17 Dedicated Standard Operating Procedures• USA Food and Drug Administration Compliant
• QAD Maintains the Qualified Hardware• QAD Maintains the Qualified Operating System• QAD Maintains the Application Environments
Scalability
Business Alignment
Operational Control
Risk Mitigation
17 Life Sciences On Demand SOPs
SOP on SOPs TrainingFacility Security
Data/NetworkBackup
DataArchiving
Network/ComputerSecurity
SoftwareInstallation
SystemSecurity Reviews
SystemChangeControl
SystemMaintenance
Recording
DisasterRecovery
RecordRetention
ElectronicMail
InternalAudits
ChangeApproval
Non-Disclosure
IssueTracking
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