Dave Medina Vice President Life Sciences QAD Inc 2 The following is intended to outline QADs general product direction It is intended for information purposes only and may not be incorporated into any contract It is not a commitment to deliver any material code functional capabi ID: 169251
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Benefits of Automating Quality Management Systems in Life Sciences
Dave Medina
Vice President – Life Sciences
QAD, Inc.Slide2
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The following is intended to outline QAD’s general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, functional capabilities, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functional capabilities described for QAD’s products remains at the sole discretion of QAD.
Disclaimer
Benefits of Automating Quality Management Systems in Life SciencesSlide3
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Why automate QMS processes?
CEBOS in the life sciences
CEBOS QMS customer experiencesVision: QAD and CEBOS integrationSummary
Agenda
Benefits of Automating Quality Management Systems in Life SciencesSlide4
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The benefits of automating QMS and integrating with QAD Enterprise Applications
Combining QAD and CEBOS helps build the Effective Enterprise by:
Providing enterprise-wide visibility into quality system management processesConnecting manufacturing and quality processesEnsuring workflow and process consistency
Session Overview
Benefits of Automating Quality Management Systems in Life SciencesSlide5
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An Effective Enterprise in Life Sciences is:
Benefits of Automating Quality Management Systems in Life Sciences
Every business process working at peak efficiency and perfectly aligned with your strategic goalsSlide6
Automating the Life Sciences Quality Management System
Benefits of Automating Quality Management Systems in Life SciencesSlide7
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Homegrown, paper or departmentalized point solutions fail to…
…offer centralized view of quality and compliance
…integrate with enterprise systems to aggregate data…connect to manufacturing processes…easily adapt to changed compliance requirements
…ensure workflow and process consistency
Why Automate QMS Processes?
Benefits of Automating Quality Management Systems in Life SciencesSlide8
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Improve quality and compliance
Increase visibility into improvements, trends and risks
Standardize processes and workflowAutomatically collect quality dataQuality visibility across value chain
Interoperability with ERP
Why Automate QMS Processes?
Benefits of Automating Quality Management Systems in Life SciencesSlide9
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Improve products
Foster best-practice quality through automation of quality processes
Build compliance into processesImplement continuous improvement by leveraging quality data
Why Automate QMS Processes?
Benefits of Automating Quality Management Systems in Life SciencesSlide10
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Reduce cycle times and resources
Streamlined workflow
Synchronize quality and manufacturingManage partners and suppliersMonitor quality and compliance performance
Why Automate QMS Processes?
Benefits of Automating Quality Management Systems in Life SciencesSlide11
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Improve compliance
Integrate quality workflows into business processes
Consistent enterprise-wide quality processesVisibility across supply chainEnhance quality and compliance governance
Why Automate QMS Processes?
Benefits of Automating Quality Management Systems in Life SciencesSlide12
CEBOS in the Life Sciences
Benefits of Automating Quality Management Systems in Life SciencesSlide13
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Life Sciences Solution
Benefits of Automating Quality Management Systems in Life Sciences
QAD Enterprise Applications
ISO 13485
GxP
21 CFR 11
Validation
Powerful Integration
ISO 14971Slide14
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Document Control
Benefits of Automating Quality Management Systems in Life
Sciences
Version Management
Single source of truth
Change control
Robust workflow
Link to Training Tracking
Secure
Controlled Access
Accessible
Easy search and organizationSlide15
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Device Master
Benefits of Automating Quality Management Systems in Life
Sciences
Device Master
Easily configurable
Device History File
Maintain and track device information
Design History File
Processes to track & store design verification and validation dataSlide16
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CAPA and Non-Conformance
Benefits of Automating Quality Management Systems in Life
Sciences
Corrective actions
Automated management
Trend analysis support
MedWatch
form 3500A
Preventive actions
Verify and document improvement actions
Links to Risk Management
Nonconformance
Simple data entry with escalation as necessarySlide17
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Complaint Handling
Benefits of Automating Quality Management Systems in Life
Sciences
Complaint management
Automated management
Trend analysis support
MedWatch
form 3500A
Corrective
actions
Configurable workflow
Enforces a disciplined problem solving
approach
Preventative actions
Verify and document improvement actionsSlide18
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Audit Management
Benefits of Automating Quality Management Systems in Life
Sciences
Compliance
Audit-based compliance approach support
Ensure best practices
Improved reporting
Highlight
areas requiring improvement
Graphic, summary or
detail
Organized
Automated management of audit functionSlide19
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Training Management
Benefits of Automating Quality Management Systems in Life
Sciences
Qualification Management
Qualified and current
Cost-effective
training
Employee tracking
Central repository and management system
Manage everything related to employee trainingSlide20
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Calibration
Benefits of Automating Quality Management Systems in Life
Sciences
Calibration Management
Optimized scheduling
Electronic approval
Disciplined tracking and maintenance
Increased
Effectiveness
Status
and trending analysis
Automated workflow managementSlide21
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Risk Management / ISO 14971
Benefits of Automating Quality Management Systems in Life
Sciences
Failure Mode Effect Analysis
Configurable FMEA tracking
Uniform method for determining
risk
Organized risk management
Risks grouped and analyzed using common criteria
Links to documents, projects, and continuous improvement items Slide22
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Supplier Management
Benefits of Automating Quality Management Systems in Life
Sciences
Supplier performance
Approved supplier list
On-time delivery, PPM and additional metrics tracking
Improved
communication
Corrective action response
Access to latest documents and specificationsSlide23
CEBOS QMS customers
Life Sciences Compliance and StandardsSlide24
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CORPAK Med Systems
Benefits of Automating Quality Management Systems in Life Sciences
Customer Profile
Challenges
Solution
U.S. medical device manufacturer of
enteral
products (
Nasogastric
(“NG”) feeding tubes,
gastrostomy
feeding tubes &
enteral
feeding safety devices
Products distributed globally (U.S., Europe, Asia, Latin America)
Recent acquisitions in the U.S. and UK
Old home grown and internally applications that were expensive to improve and maintain
No integration of applications or data
CEBOS CAPA for Customer Complaints
SCARs
with electronic approval, & routing
CEBOS Gage for calibration
Documents to manage revisions, approval routing, and control.
Paperless training management system
Audit management module with CAPA integrationSlide25
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X-Gen Pharmaceuticals
Benefits of Automating Quality Management Systems in Life Sciences
Customer Profile
Challenges
Solution
U.S. based manufacturer of
mature generic pharmaceuticals
Products include
injectables
,
inhalents
, oral, topical and specialty
pharmacueticals
CAPA managed using Excel
Access files for quality data
No automated workflow routing
Poor visibility into quality trends
CEBOS CAPA Module for CAPA mgmt
Workflow, notifications, routing is automatic
Easy visibility to status by all
More robust security model
Used CEBOS built-in reports and charts for trendingSlide26
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Tecomet
Benefits of Automating Quality Management Systems in Life Sciences
Customer Profile
Challenges
Solution
U.S. based supplier of critical components for medical implants
Serves markets in orthopedic, trauma, extremities, radiology, dental, spine, CMF and cardiovascular
Compliance with ISO 13485 (GMP for medical devices)
Inadequate document
revisioning
and control
Training not integrated with document changes
Tight integration with medical device manufacturer supply chain
CEBOS Documents:
Automatic retention
Revision approval routing and history
Release control
Training Management :
Triggers training when when documents go through significant revision changes
Manage training planning and training historySlide27
Vision: QAD and CEBOS integration
Benefits of Automating Quality Management Systems in Life SciencesSlide28
Drug Recall
Benefits of Automating Quality Management Systems in Life Sciences
FDA First Alert
Distributor
Pharmacy
Class I Recall
FDA Alerts Public
Manufacturer
Data Capture for Recall EffectivenessSlide29
Integrated Recall and CAPA Data
Benefits of Automating Quality Management Systems in Life Sciences
Complaint
ePedigree
Manufacturer
Data for CAPA
QAD
Data
Supplier
Lot Trace – Back
Supply Chain Partners
Lot Trace – ForwardSlide30
Recall: ERP and CAPA Integration
Benefits of Automating Quality Management Systems in Life Sciences
FDA Effectiveness Check
CAPA
Investigation
Action
Data from QAD
Verification & DocumentationSlide31
Integration for Quality Management
Benefits of Automating Quality Management Systems in Life Sciences
QAD Enterprise Applications
Quality Management Software
Supplier data
Lot/product data
Product QC data
Quality trend data
Change control
Other ERP data
For quality mgmtSlide32
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Summary
Benefits of Automating Quality Management Systems in Life SciencesSlide33
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Integrating QAD with CEBOS QMS…
…Improves quality and compliance
…Improves products
…Reduces cycle times and resources
QAD & CEBOS Integration
Benefits of Automating Quality Management Systems in Life SciencesSlide34
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Dave Medina,
Vice President, Life Sciences
QAD, Inc. d6m@qad.com
Questions & Answers
Benefits of Automating Quality Management Systems in Life SciencesSlide35
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Attend these related sessions:
Managing Quality and Compliance
Conquering Serialized Inventory ManagementStop by the Solutions ExpoContact your QAD representative
Next Steps
Full Session TitleSlide36
www.qad.com
©QAD Inc. 2013
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