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Transcript of | Building the Effective Enterprise Benefits of Automating Quality Management Systems in Life...
| Building the Effective Enterprise
Benefits of Automating Quality Management Systems in Life Sciences
Dave MedinaVice President – Life SciencesQAD, Inc.
| Building the Effective Enterprise 2
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 Sciences
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■Why automate QMS processes?■CEBOS in the life sciences■CEBOS QMS customer experiences■Vision: QAD and CEBOS integration■Summary
Agenda
Benefits of Automating Quality Management Systems in Life Sciences
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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 processes Connecting manufacturing and quality
processes Ensuring workflow and process consistency
Session Overview
Benefits of Automating Quality Management Systems in Life Sciences
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An Effective Enterprise in Life Sciences is:
Benefits of Automating Quality Management Systems in Life Sciences
•Manufactures safe and effective products for patient care
Patient-Focused
•Complies with applicable global regulations and requirements
Compliant
•Innovates to improve all aspects of their operations
Innovative
Every business process working at peak efficiency and perfectly aligned with your
strategic goals
| Building the Effective Enterprise
Automating the Life Sciences Quality Management System
Benefits of Automating Quality Management Systems in Life Sciences
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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 Sciences
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■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
Why Automate QMS Processes?
Benefits of Automating Quality Management Systems in Life Sciences
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■Improve products Foster best-practice quality through
automation of quality processes Build compliance into processes Implement continuous improvement by
leveraging quality data
Why Automate QMS Processes?
Benefits of Automating Quality Management Systems in Life Sciences
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■Reduce cycle times and resources Streamlined workflow Synchronize quality and manufacturing Manage partners and suppliers
−Monitor quality and compliance performance
Why Automate QMS Processes?
Benefits of Automating Quality Management Systems in Life Sciences
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■Improve compliance Integrate quality workflows into business
processes Consistent enterprise-wide quality
processes Visibility across supply chain
−Enhance quality and compliance governance
Why Automate QMS Processes?
Benefits of Automating Quality Management Systems in Life Sciences
| Building the Effective Enterprise
CEBOS in the Life Sciences
Benefits of Automating Quality Management Systems in Life Sciences
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Life Sciences Solution
Benefits of Automating Quality Management Systems in Life Sciences
Document Control
Device Master
CAPA / NCR
Complaint Handling
Audit Mgmt.
Training Mgmt.
Calibration
Risk Mgmt./ ISO 14971
Supplier Mgmt.
QAD Enterprise
Applications
ISO 13485
GxP
21 CFR 11
Validation
Powerful Integration
ISO 14971
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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
organization
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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 data
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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 necessary
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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 actions
Document Contr
ol
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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 function
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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 training
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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
management
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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
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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 specifications
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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 integration
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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 trending
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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 history
| Building the Effective Enterprise
Vision: QAD and CEBOS integration
Benefits of Automating Quality Management Systems in Life Sciences
| Building the Effective Enterprise
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 Effectiveness
| Building the Effective Enterprise
Integrated Recall and CAPA Data
Benefits of Automating Quality Management Systems in Life Sciences
Complaint
ePedigree
Manufacturer
Data for CAPA
QADData
Supplier
Lot Trace – Back
Supply Chain
PartnersLot Trace – Forward
| Building the Effective Enterprise
Recall: ERP and CAPA Integration
Benefits of Automating Quality Management Systems in Life Sciences
FDA Effectiveness Check
CAPAInvestigati
on Action
Data from QAD
Verification & Documentation
| Building the Effective Enterprise
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 mgmt
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Summary
Benefits of Automating Quality Management Systems in Life Sciences
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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 Sciences
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■Dave Medina, Vice President, Life SciencesQAD, Inc.
Questions & Answers
Benefits of Automating Quality Management Systems in Life Sciences
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■Attend these related sessions: Managing Quality and Compliance Conquering Serialized Inventory Management
■Stop by the Solutions Expo■Contact your QAD representative
Next StepsFull Session Title