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Benefits of QAD QMS in Life Science Benefits of QAD QMS in Life Science Toni Clubb, CFO, VitaTech Jeff Phillips, VP Product Management, QAD LEARN. #QADexplore NETWORK. DISCOVER. LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science Safe Harbor Statement 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. #QADexplore 2 LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science Introductions Jeff Phillips CEBOS, a division of QAD - VP of Product Management - 20 years designing, developing, supporting and servicing Enterprise Quality Management Systems Toni Clubb Vitatech Nutritional Sciences, Inc. - Chief Financial Officer - QAD user for 10 years #QADexplore 3 LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science Agenda Vitatech Company Overview Vitatech Quality Department Functional Requirements QAD QMS Overview Vitatech Project #QADexplore 4 LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science Vitatech Overview Leader in nutritional supplement manufacturing industry FDA licensed for 60 years A Tradition of Excellence ™ #QADexplore 5 LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science Vitatech Overview Custom nutritional solutions Dietary powders, tablets & two piece capsules Make to Order & Make to Stock Fulfillment to mass market distribution centers State of the art technology #QADexplore 6 LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science Vitatech QAD Timeline Initial Go Live • 55 Users • Desktop UI • Core Product • Enhanced Controls • Radley Data Collection • Cyberquery #QADexplore Upgrade to .Net • 65 Users • New .NetUI • Core Product • Enhanced Controls • Radley Data Collection • Cyberquery 7 LEARN. Upgrade to EE • 75 Users • Core Product • Enhanced Controls • Radley Data Collection • Cyberquery • EDI NETWORK. DISCOVER. Benefits of QAD QMS in Life Science Vitatech QAD Timeline continued Upgrade to Quality Module • 100 Users • Core Product • Enhanced Controls • Radley Data Collection • Cyberquery • EDI #QADexplore Implement QAD QMS System • 50 QMS Users • APQP (Device/Batch Master) • Inspection & SPC • CAPA & NCR • Integration 8 LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science Vitatech QAD Users by Functional Area Purchasing, 4 Data Control, 3 Document Control, 8 Quality, 31 IT/System, 4 Accounting/ Admin, 5 R&D, 5 Open, 2 Sales, 6 Shipping/Receiving, 10 Weighing, 7 Operations, 7 Planning, 7 #QADexplore 9 LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science Vitatech Quality Department Functional Requirements Benefits of QAD QMS in Life Science #QADexplore LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science Vitatech Quality Department Principles Ensure Vitatech maintains our FDA pharmaceutical license and makes certain that the company is in compliance with all cGMP requirements Facilitate and enable the use of quality standards to motivate continuous improvement in process capabilities Maintain all current industry certifications Develop and maintain quality management systems that operate efficiently and effectively in processing quality orders and quality reporting in all areas #QADexplore 11 LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science Vitatech Quality Dept. Critical Needs Quality master data - Electronic signatures - Attachment capabilities - Master file templates Quality inspection - System generated test results Electronic approval and routing Data analysis, including trending of test results Mobile device data entry Electronic certificates of analysis Implement a CAPA / NCR program #QADexplore 12 LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science QAD QMS Overview Benefits of QAD QMS in Life Science #QADexplore LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science QAD QMS Module Overview CAPA & NCR Audit Mgmt. APQP Document Control Integration Inspections & SPC Go Live Module #QADexplore Calibration Training Mgmt. Supplier Mgmt. 14 LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science QAD QMS Configuration Add/Remove fields Workflow your way #QADexplore 15 Required fields Rules that automated your business Metrics / KPIs Integrate additional apps EOB Templates LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science QAD QMS Reporting Powerful charts and data analysis Crosstab Include pictures and graphics User defined Built in with EOB #QADexplore 16 LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science QAD QMS Action Manager E-mail or in application Personalized to do list Delegation User defined Automatically drive your process #QADexplore 17 LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science Vitatech Project Benefits of QAD QMS in Life Science #QADexplore LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science Vitatech Decision Which System? Item Attributes and Quality Control in the ERP #QADexplore OR 19 APQP and Inspections in QMS LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science System Functionality Comparison User Requirements Test Specification Reporting System Generated Quality Orders Audit Trails Electronic C of A Mobile Device Entry of Inspection Results Attributes & Quality QAD QMS Integrated Document Management System #QADexplore 20 LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science System Functionality Comparison User Requirements Attributes & Quality Electronic Signature Electronic Version Control Email Notification of Tasks Attachments for Lab Results CAPA/NCR Functionality #QADexplore 21 QAD QMS LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science Vitatech System Design Quality Master Data QAD QMS Q-Xtend Production #QADexplore Inspection Records e-Signed Records QAD ERP 22 LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science Sample System Design Flowchart #QADexplore 23 LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science QMS Project Timeline TASKS JUL AUG SEP OCT NOV DEC Requirement Definitions QMS System Software Training (Cloud) System Design for Vitatech Configuration Hardware & Software Installation(on premises) #QADexplore 24 LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science QMS Project Timeline continued TASKS JUL AUG SEP OCT NOV DEC Q-Extend Integration Mapping Validation Activities End User Training Update All Affected SOP's & Process Maps GO LIVE Phase II Expanding All Areas #QADexplore 25 LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science Vitatech and QAD QMS QMS changes documentation practice Quality procedures do Not Change #QADexplore 26 LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science Vitatech Next Steps Full company rollout – all product lines #QADexplore 27 LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science Questions & Answers Toni Clubb: [email protected] Jeff Phillips: [email protected] #QADexplore 28 LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science Next Steps Attend these related sessions: - Tracking and Product Genealogy - Improving Operational Efficiency Stop by the Solutions Expo #QADexplore 29 LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science Explore 2015 – Must See Presentation! The Challenge of the Lean Enterprise - James Womack – Founder of The Lean Enterprise Institute Author of “The Machine That Changed the World” Author of “Lean Thinking, Lean Solutions and The Lean Turnaround” - Tuesday, 1:30-2:30 - Maryland Ballroom #QADexplore 30 LEARN. NETWORK. DISCOVER. Benefits of QAD QMS in Life Science www.qad.com ©QAD Inc. 2015 #QADexplore 31 LEARN. NETWORK. DISCOVER.