QAD Quality Management Systems Roll Out November 17, 2014

 Vitatech Company Overview  Quality Department Functionality Requirements  QAD-QMS System Overview  Vitatech QAD-QMS Integration Design  Project Plan Implementation Timetable  Examples of Electronic Signature & Reporting Outline 2

 A leader in the nutritional supplement manufacturing industry  Sixty years-FDA licensed contract manufacturer of dietary powders, tablets & two piece capsules  A Tradition of Excellence ™  Custom nutritional solutions − Make to Order & Make to Stock − Fulfillment to mass market distribution centers  State of the art technology VITATECH Nutritional Sciences Overview

QAD Upgrade History Time Line Initial Go Live 55 Users Desktop UI Core Product Enhanced Controls Radley Data Collection Cyberquery Upgrade to.Net 65 Users New.Net UI Core Product Enhanced Controls Radley Data Collection Cyberquery Upgrade to EE 75 Users Core Product Enhanced Controls Radley Data Collection Cyberquery EDI Upgrade to Quality Module 100 Users Core Product Enhanced Controls Radley Data Collection Cyberquery EDI Implement QAD QMS System 50 QMS Users APQP (Device/ Batch Master) Inspection & SPC CAPA & NCR Integration

Overview of QAD Users by Functional Area

 Ensure Vitatech maintains our FDA pharmaceutical license and makes certain that the company is in compliance with all cGMP requirements.  To facilitate and enable the use of quality standards to motivate continuous improvement in process capabilities.  To maintain all current industry certifications.  To develop and maintain quality management systems that operate efficiently and effectively in processing quality orders and quality reporting in all areas. Quality Department Principles 6

 Quality Master Data − Electronic Signatures − Attachment capability − Master file templates  Quality Inspection − System generated test results − Electronic approval & routing − Data Analysis including trending of test results − Mobile Device Data Entry  Electronic Certificates of Analysis  Implement a CAPA/NCR program Vitatech Critical Quality Department Needs 7

High Level Quality Management System Overview 8 APQP (Device/Batch Master) Inspections & SPC CAPA & NCR Audit Management Training Management Calibration Document Control Supplier Management Powerful Integration QAD ERP System QAD QMS Go Live Module

9  APQP (Device / Batch Master)  Audit Mgmt  CAPA & NCR  Document Mgmt  Calibrations (Gauge Tracking)  Inspection / SPC  Supplier Mgmt  Training Mgmt Process Flow (Routing) Process FMEA (Hazard Analysis) Process Control Plan (Inspection plan) PPAP (Production Part Approval Process) Work Instructions Module Descriptions Audit Questions / Checklists Internal Audit Schedule LPA (Layered Process Audits) Other Audits for example Safety CAPA (Corrective & Preventive Actions) NCR (Non- conformance) Quality Alerts RMA (Returned Material Authorizations) Analysis Controlled Documents Engineering Changes Records Manuals Gauge Tracking Gauge Calibration Schedule / History MSA (Measurement System Analysis) study tracking Quality Order Tracking Inspection Event and Results SPC (Statistical Process Control) Charts Trigger Events based on Rules (WECO) Approved Supplier List Supplier Performance Reviews Supplier Audits Skill Management Training Tracking Employee Certifications Links to Documents module

10 Configuration  Add/Remove fields − Fields can be added or removed to support the requirements of configured processes.  Workflow − Workflows of processes are secure and easily modified to automate and facilitate the completion of business processes.  Required Fields − Enforce data entry and enable desired, appropriate data to be entered with the ability to configure drop down lists.  EOB Templates − Best practices which can be easily modified to meet your business needs.

11  Built In − Easy onboading processes contain built in reports.  Powerful − Reports can contain data from multiple processes displaying charts, pictures as well as analysis data.  Crosstab − Easily review data organized by common groups such as months, quarters or departments.  User defined − Available report designer, allows for user defined reports available directly from the user interface. Reporting

12  Automated − Notify users when they have tasks or approvals waiting for them. Automatically escalate problems to management.  − Clicking hyperlinks embedded within the opens the application to the exact place where the work gets completed  To Do List − All actions are available for a logged in user from a dashboard list in the application.  User defined − Simple and quick configuration of user defined actions to support your process. Action Manager

Item Master and Transaction Data Master Quality Records and Inspection Records Vitatech Design Official records, e-Signed QXtend Master Data Select Activities Quality Master Data Quality documents finalized with attachments and approved in QMS ERP System 4 Quality Orders & Inspection Records Production QMS

User RequirementsQAD Quality ModuleQAD QMS Test Specification Reporting System Generated Quality Orders Audit Trails Electronic C of A Mobile Device Entry of Inspection Results Integrated Document Management System Electronic Signature Electronic Version Control Notification of Tasks Attachments for Lab Results CAPA/NCR Functionality System Functionality Comparison

QMS Project Timeline TASKSJULAUGSEPTOCTNOVDEC Requirement Definitions QMS System Software Training (Cloud) System Design for Vitatech Configuration Hardware & Software Installation (on premises) Q-Extend Integration Mapping Validation Activities End User Training Update All Affected SOP's & Process Maps GO LIVE Phase II Expanding All Areas

16 System Design Flow Chart

Vitatech and QAD QMS  QMS changes documentation practice  Quality procedures do Not Change 17

Approval – E Signature 18

19 Next Steps…Full Company Rollout All Product Lines

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