| Building the Effective Enterprise Benefits of Automating Quality Management Systems in Life Sciences Dave Medina Vice President – Life Sciences QAD,

| Building the Effective Enterprise

Benefits of Automating Quality Management Systems in Life Sciences

Dave MedinaVice President – Life SciencesQAD, Inc.

| Building the Effective Enterprise 2

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Disclaimer



■Why automate QMS processes?■CEBOS in the life sciences■CEBOS QMS customer experiences■Vision: QAD and CEBOS integration■Summary

Agenda



■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



An Effective Enterprise in Life Sciences is:


•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


Automating the Life Sciences Quality Management System



■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?



■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




■Improve products Foster best-practice quality through

automation of quality processes Build compliance into processes Implement continuous improvement by

leveraging quality data




■Reduce cycle times and resources Streamlined workflow Synchronize quality and manufacturing Manage partners and suppliers

−Monitor quality and compliance performance




■Improve compliance Integrate quality workflows into business

processes Consistent enterprise-wide quality

processes Visibility across supply chain

−Enhance quality and compliance governance




CEBOS in the Life Sciences



Life Sciences Solution


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

http://www.qad.com/erp


Document Control


■Version Management• Single source of truth

■Change control• Robust workflow• Link to Training Tracking

■Secure• Controlled Access

■Accessible• Easy search and

organization


Device Master


■Device Master• Easily configurable

■Device History File• Maintain and track device

information

■Design History File• Processes to track & store

design verification and validation data


CAPA and Non-Conformance


■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


Complaint Handling


■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


Audit Management


■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


Training Management


■Qualification Management• Qualified and current• Cost-effective training

■Employee tracking• Central repository and

management system• Manage everything related

to employee training


Calibration


■Calibration Management• Optimized scheduling• Electronic approval• Disciplined tracking and

maintenance

■Increased Effectiveness• Status and trending analysis• Automated workflow

management


Risk Management / ISO 14971


■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


Supplier Management


■Supplier performance• Approved supplier list• On-time delivery, PPM and

additional metrics tracking

■Improved communication• Corrective action response• Access to latest documents

and specifications


CEBOS QMS customersLife Sciences Compliance and Standards


CORPAK Med Systems


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


X-Gen Pharmaceuticals



•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


Tecomet



•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


Vision: QAD and CEBOS integration



Drug Recall


FDA First Alert

Distributor

Pharmacy

Class I Recall

FDA Alerts Public

Manufacturer

Data Capture for Recall Effectiveness


Integrated Recall and CAPA Data


Complaint

ePedigree

Manufacturer

Data for CAPA

QADData

Supplier

Lot Trace – Back

Supply Chain

PartnersLot Trace – Forward


Recall: ERP and CAPA Integration


FDA Effectiveness Check

CAPAInvestigati

on Action

Data from QAD

Verification & Documentation


Integration for Quality Management


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


Summary



■Integrating QAD with CEBOS QMS…■…Improves quality and compliance■…Improves products■…Reduces cycle times and resources

QAD & CEBOS Integration



■Dave Medina, Vice President, Life SciencesQAD, Inc.

[email protected]

Questions & Answers


mailto:[email protected]


■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


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