Benefits of Automating Quality
Management Systems in Life Sciences
Dave Medina
Vice President – Life Sciences
QAD, Inc.
| Building the Effective Enterprise
Benefits of Automating Quality Management Systems in Life Sciences
Disclaimer
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.
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Benefits of Automating Quality Management Systems in Life Sciences
Agenda
■
■
■
■
■
Why automate QMS processes?
CEBOS in the life sciences
CEBOS QMS customer experiences
Vision: QAD and CEBOS integration
Summary
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Benefits of Automating Quality Management Systems in Life Sciences
Session Overview
■ 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 processes
 Connecting manufacturing and quality
processes
 Ensuring workflow and process consistency
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Benefits of Automating Quality Management Systems in Life Sciences
Every business process working at peak efficiency
and perfectly aligned with your strategic goals
An Effective Enterprise in Life Sciences is:
PatientFocused
• Manufactures safe and effective
products for patient care
Compliant
• Complies with applicable global
regulations and requirements
Innovative
• Innovates to improve all aspects
of their operations
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Benefits of Automating Quality Management Systems in Life
Sciences
Automating the Life Sciences Quality
Management System
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Benefits of Automating Quality Management Systems in Life Sciences
Why Automate QMS Processes?
■ 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
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Benefits of Automating Quality Management Systems in Life Sciences
Why Automate QMS Processes?
■ Improve quality and compliance
 Increase visibility into improvements,
trends and risks
 Standardize processes and workflow
 Automatically collect quality data
 Quality visibility across value chain
 Interoperability with ERP
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Benefits of Automating Quality Management Systems in Life Sciences
Why Automate QMS Processes?
■ Improve products
 Foster best-practice quality through
automation of quality processes
 Build compliance into processes
 Implement continuous improvement by
leveraging quality data
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Benefits of Automating Quality Management Systems in Life Sciences
Why Automate QMS Processes?
■ Reduce cycle times and resources
 Streamlined workflow
 Synchronize quality and manufacturing
 Manage partners and suppliers
− Monitor quality and compliance performance
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Benefits of Automating Quality Management Systems in Life Sciences
Why Automate QMS Processes?
■ Improve compliance
 Integrate quality workflows into business
processes
 Consistent enterprise-wide quality processes
 Visibility across supply chain
− Enhance quality and compliance governance
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Benefits of Automating Quality Management Systems in Life
Sciences
CEBOS in the Life Sciences
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Benefits of Automating Quality Management Systems in Life Sciences
Life Sciences Solution
Document
Control
ISO 13485
21 CFR 11
QAD
Enterprise
Applications
Device
Master
CAPA / NCR
Validation
Complaint
Handling
Powerful
Integration
Audit Mgmt.
Training
Mgmt.
ISO 14971
GxP
Supplier
Mgmt.
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Risk Mgmt./
ISO 14971
Calibration
13
Benefits of Automating Quality Management Systems in Life Sciences
Document Control
■ Version Management
• Single source of truth
Document
Control
Device
Master
■ Change control
Complain
t Handling
• Robust workflow
• Link to Training Tracking
Audit
Mgmt.
■ Secure
Training
Mgmt.
• Controlled Access
■ Accessible
• Easy search and
organization
| Building the Effective Enterprise
CAPA /
NCR
Calibration
Supplier
Mgmt.
Risk Mgmt./
ISO 14971
14
Benefits of Automating Quality Management Systems in Life Sciences
Device Master
■ Device Master
• Easily configurable
Device Master
Document
Control
CAPA /
NCR
■ Device History File
Complain
t Handling
• Maintain and track device
information
Audit
Mgmt.
■ Design History File
• Processes to track & store
design verification and
validation data
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Training
Mgmt.
Supplier
Mgmt.
Risk
Mgmt./
ISO 14971
Calibration
15
Benefits of Automating Quality Management Systems in Life Sciences
CAPA and Non-Conformance
■ Corrective actions
• Automated management
• Trend analysis support
• MedWatch form 3500A
Document
Control
Device
Master
Complain
t Handling
■ Preventive actions
Audit
Mgmt.
• Verify and document
improvement actions
• Links to Risk Management
■ Nonconformance
CAPA
&
NCR
Training
Mgmt.
Supplier
Mgmt.
Risk
Mgmt./
ISO 14971
Calibration
• Simple data entry with
escalation as necessary
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Benefits of Automating Quality Management Systems in Life Sciences
Complaint Handling
■ Complaint management
• Automated management
• Trend analysis support
• MedWatch form 3500A
Document
Control
Device
Master
Complaint
Handling
■ Corrective actions
Audit
Mgmt.
• Configurable workflow
• Enforces a disciplined problem
solving approach
■ Preventative actions
CAPA /
NCR
Training
Mgmt.
Supplier
Mgmt.
Risk
Mgmt./
ISO 14971
Calibratio
n
• Verify and document
improvement actions
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Benefits of Automating Quality Management Systems in Life Sciences
Audit Management
■ Compliance
• Audit-based compliance
approach support
• Ensure best practices
Document
Control
Device
Master
CAPA /
NCR
Complain
t Handling
■ Improved reporting
Audit
Mgmt.
• Highlight areas requiring
improvement
• Graphic, summary or detail
■ Organized
Training
Mgmt.
Supplier
Mgmt.
Risk
Mgmt./
ISO 14971
Calibration
• Automated management of
audit function
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Benefits of Automating Quality Management Systems in Life Sciences
Training Management
■ Qualification
Management
Document
Control
Device
Master
• Qualified and current
• Cost-effective training
Complain
t Handling
■ Employee tracking
• Central repository and
management system
• Manage everything related
to employee training
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CAPA /
NCR
Audit
Mgmt.
Training
Mgmt.
Supplier
Mgmt.
Risk
Mgmt./
ISO 14971
Calibration
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Benefits of Automating Quality Management Systems in Life Sciences
Calibration
■ Calibration
Management
Document
Control
Device
Master
• Optimized scheduling
• Electronic approval
• Disciplined tracking and
maintenance
Complain
t Handling
Audit
Mgmt.
Training
Mgmt.
■ Increased Effectiveness
• Status and trending analysis
• Automated workflow
management
| Building the Effective Enterprise
CAPA /
NCR
Supplier
Mgmt.
Risk
Mgmt./
ISO 14971
Calibration
20
Benefits of Automating Quality Management Systems in Life Sciences
Risk Management / ISO 14971
■ Failure Mode Effect
Analysis
Document
Control
• Configurable FMEA tracking
• Uniform method for determining risk
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CAPA /
NCR
Complaint
Handling
■ Organized risk
management
• Risks grouped and analyzed using
common criteria
• Links to documents, projects, and
continuous improvement items
Device
Master
Audit
Mgmt.
Training
Mgmt.
Calibration
Supplier
Mgmt.
Risk Mgmt./
ISO 14971
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Benefits of Automating Quality Management Systems in Life Sciences
Supplier Management
■ Supplier performance
• Approved supplier list
• On-time delivery, PPM and
additional metrics tracking
Document
Control
Device
Master
Complain
t Handling
■ Improved
communication
• Corrective action response
• Access to latest documents
Supplier
and specifications
Mgmt.
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CAPA /
NCR
Audit
Mgmt.
Training
Mgmt.
Calibration
APQP/Ris
k Mgmt.
22
Life Sciences Compliance and Standards
CEBOS QMS customers
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Benefits of Automating Quality Management Systems in Life Sciences
CORPAK Med Systems
Customer Profile
• 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)
Challenges
• Recent
acquisitions in the
U.S. and UK
Solution
• CEBOS CAPA for
Customer Complaints
• SCARs with electronic
approval, & routing
• Old home grown
and internally
• CEBOS Gage for
applications that
calibration
were expensive to
• Documents to manage
improve and
revisions, approval
maintain
routing, and control.
• No integration of
• Paperless training
applications or
management system
data
• Audit management
module with CAPA
integration
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Benefits of Automating Quality Management Systems in Life Sciences
X-Gen Pharmaceuticals
Customer Profile
• U.S. based
manufacturer of
mature generic
pharmaceuticals
• Products include
injectables, inhalents,
oral, topical and
specialty
pharmacueticals
Challenges
• CAPA managed
using Excel
Solution
• CEBOS CAPA Module
for CAPA mgmt
• Access files for quality • Workflow,
data
notifications, routing is
automatic
• No automated
workflow routing
• Poor visibility into
quality trends
• Easy visibility to status
by all
• More robust security
model
• Used CEBOS built-in
reports and charts for
trending
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Benefits of Automating Quality Management Systems in Life Sciences
Tecomet
Customer Profile
• U.S. based supplier
of critical
components for
medical implants
Challenges
• Compliance with ISO
13485 (GMP for
medical devices)
Solution
• CEBOS Documents:
- Automatic retention
- Revision approval
routing and history
• Inadequate
• Serves markets in
document revisioning
- Release control
orthopedic, trauma, and control
• Training Management :
extremities,
• Training not
radiology, dental,
- Triggers training when
integrated with
spine, CMF and
when documents go
document changes
cardiovascular
through significant
• Tight integration with
revision changes
medical device
- Manage training
manufacturer supply
planning and training
chain
history
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Benefits of Automating Quality Management Systems in Life
Sciences
Vision: QAD and CEBOS integration
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Benefits of Automating Quality Management Systems in Life Sciences
Drug Recall
FDA First Alert
Manufacturer
Class I
Recall
FDA Alerts
Public
Distributor
Pharmacy
Data Capture for Recall Effectiveness
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Benefits of Automating Quality Management Systems in Life Sciences
Integrated Recall and CAPA Data
Lot Trace – Forward
Supplier
QAD
Data
Manufacturer
Lot Trace – Back
Data for CAPA
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Supply
Chain
Partners
Complaint
Benefits of Automating Quality Management Systems in Life Sciences
Recall: ERP and CAPA Integration
Data from QAD
CAPA
Investigation
Verification & Documentation
FDA Effectiveness
Check
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Action
Benefits of Automating Quality Management Systems in Life Sciences
Integration for Quality Management
Supplier data
Lot/product data
Product QC data
QAD
Enterprise
Applications
Quality trend data
Change control
Other ERP data
For quality mgmt
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Quality
Management
Software
Benefits of Automating Quality Management
Systems in Life Sciences
Summary
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Benefits of Automating Quality Management Systems in Life Sciences
QAD & CEBOS Integration
■ Integrating QAD with CEBOS QMS…
■ …Improves quality and compliance
■ …Improves products
■ …Reduces cycle times and resources
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Benefits of Automating Quality Management Systems in Life Sciences
Questions & Answers
■ Dave Medina,
Vice President, Life Sciences
QAD, Inc.
d6m@qad.com
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Full Session Title
Next Steps
■ Attend these related sessions:
 Managing Quality and Compliance
 Conquering Serialized Inventory Management
■ Stop by the Solutions Expo
■ Contact your QAD representative
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www.qad.com
©QAD Inc. 2013
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