October 2015

Next Generation EQMS Solution

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Outline

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About Qualityze Background – Current State Process

Next GenerationEnterprise Quality Management

Questions and Next Steps

About Qualityze• Accomplished Leadership Team with extensive Quality, Compliance, and Process

Management experience

• Quality Domain Expertise in Manufacturing, Distribution, Service, and Regulated Industries such as Life Sciences with Fortune 2000 companies

• Salesforce OEM Partner. Experts of Salesforce Platform and its development

• Strong Product Development / Technology expertise. Qualityze global offices and product support team cover all global time zones

• Qualityze EQMS is • SaaS Subscription based with selectable Modules or complete EQMS Suite• Built on Salesforce platform and hosted on the secure scalable Salesforce cloud (ISO 27001 compliant)• Qualityze EQMS is administrable, configurable, provides managed workflows with best practices, approvals,

emails alerts, analytics etc. The user interface is exceptional and easy to use

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Nonconformance Management

Software

Corrective Action Preventative Action

Management (CAPA

) Software

Document Management Software

Training Management Software

Audit Management Software

Complaint Management Software

Change Management Software

Supplier Quality

Management Software

Qualityze Solutions for EQMS

Current State ProcessBackground Systems: • Verint DA, CRM, BI and others• Currently more manual dis-aggregated processes for Quality defects, Action Plans, Employee Training and Audits • Command Center• Verint Triggers & QM• Qualityze Document Management with Change Control (NC & CAPA to be scheduled)

Current State Challenges

• Continuous improvement of Customer interactions and quality performance (end customers and clients)• Revenue impact• Lower Labor cost through increased efficiency• Ability to see risks that need to be mitigated is challenging• No integrated system for Quality Management• Disconnected system for partial quality data and provides incomplete systems for quality defect tracking• Audit system is not integrated to quality process such as defect tracking analysis, CAPA, document management, change management

therefore audit outcomes cannot be tied to quality record for effective data analysis• Employee training is not tied to control documents for enforced document training and compliance

All of the above leads to a disaggregated model that cannot provide holistic systems & processes needed to deliver efficiencies, better support decisions, and easily drive higher operational quality and customer satisfaction

Current State – Complex Semi-Disaggregated (Spaghetti Model)

Ops

Data MGT & KB

Sales

Objectives with Metrics

Align Quality to Customer

Quality Team

Analyze data and triggers for quality. Find positive and negative trends

Develop concise and specific action plans. Correct deficiencies and share best practices

Distribute information to appropriate owners expediently and efficiently

Align Quality technology to objectives

Combine Cockpit and Command Center data to decision making engine

Training & Coaching

Feedback to and from customer

CRM

Verint DA

Cockpit

Verint QM & Triggers

BI / Command

Center Reporting

Optimize process, 6 sigma,

ISO adherence

Document Management w/Change Control

Desired StateObjectives:

• Timely and evidence based decision making• Provide high Customer Satisfaction with continuous feedback loops efficiently and effectively • Quality Management Framework supported with holistic integrated and managed quality processes• Integration of data from all managed processes (NC, CAPA, DOC, Training, Audit and others) to BI and Command

Center Reporting• Adherence to ISO and lean 6 sigma best practices • COE for Quality

Values Of Solution

• Executive decision making is provided the highest level of meaningful data and dashboard visibility, real time knowledge, trending, risk awareness, alerts, reporting and better analytics to support meeting objectives

• Lower labor cost due to higher efficiencies and the right information in hand• Provide SSI team with EQMS enabled and easier processes to provide adherence to best practices• Better and actionable quality data to drive higher customer satisfaction

All of the above EQMS benefits transforms your quality into a decision making engine

Quality IncidentsRoot Causes/Action Plans

Controlled DocumentsChange ControlTraining Records

AuditsSupplier Quality

Managed Process

NC Mgt

CAPA

Supplier Quality

Change Mgt

Document Mgt

Training Mgt

Customer Complaints

Audit Mgt

Future State SSI Integrated

Enterprise Quality Management

System

Quality management is an evolving practice in businesses. The ISO regulations such as ISO 9001 helps organization to improve performance and provides a platform for sustainable growth. ISO employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking.

Qualityze modules are developed based on the ISO 9001 quality management standards and QS/GMP standards of FDA. Qualityze standard processes are designed utilizing the PDCA methodology which helps to facilitate compliance by providing:

Electronic Signature Support. Audit trail (traceability – who did it, when was it done and what was changed). Timely resolution of quality incidents (CAPA, NCR). Electronic reporting and trending for management to Act vs React. Closed loop integration within the module to track the quality incidents from inception to closure to effectiveness of

resolution. Automated periodic review of active (‘Current’) document.

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Qualityze EQMS supports SREV ISO

Create Change Request Create New document

Expire a documentRevise a documentTemporary deviationObsolete document

Change request complete?Was it on time?

Change Managem

ent

Who is the owner?What is the due date?What documents are impacted?Type of change?

CAPA

Document Management

Plan

Do

Check

Act

Who is the owner?What is the due date?Type of change?Confidential document?Who has access (create, modify, view, print, download)

Document still valid?Start Effectiveness Review

Create documentCollaborate?ApproveRelease

Traceability

Complete Action plan

Non-Conformance

Continual Improvement

Training Management

Audit Management

Customer complaints

Supplier Management

Plan Do Check Act (PDCA) methodology – Change Management & Document Management

Electronic Signature Audit trail

Assess for CAPA

Open NC recordSegregate product

Verify Effectiveness of CAPAVerify problem is resolvedMonitor Trend

CAPA Managem

ent

Who is the owner?CAPA TeamWhat is the due date?Scope of CAPAImpacted site/process/product

Document Management

CAPA Management

Plan

Do

Check

Act

Verify Effectiveness of action plansVerify problem is resolvedMonitor Trend

Root Cause investigationDisposition productsDefine Action plansImplement Action plansAssess for CAPA

Traceability

Conduct Root Cause investigationVerify and Validate Action plansImplement action plans

Change Management

Continual Improvement

Training Management

Audit Management

Customer complaints

Supplier Management

Plan Do Check Act (PDCA) methodology – CAPA Management & Non Conformance Management

Electronic Signature Audit trail

Risk Assessment

Who is the owner?MRB TeamWhat is the due date?Scope of NCImpacted process/product

Risk Assessment

Management Responsibility

• Management Responsibility

• Quality Policy & Objectives

• Customer Focus & Customer Satisfaction

• Corrective and Preventive Actions

• Effective Management Review

Resource Management

• Personnel & Training

• Resource Management

Product Realization

• Customer Related Processes

• Design and Development

• Purchasing

Measurement, Analysis and

Improvement

• Customer Satisfaction• Internal Audits• Control of Non-

Conforming Product• Corrective and

Preventive Action (CAPA)

• Continual Improvement

• Quality Management System

• Documentation Requirements

• Control of Documents

General Requirements

CAPA Management

NC ManagementChange Management

Training ManagementDashboards, User portals

Audit ManagementDoc Management

Complaint ManagementTraining ManagementDashboards, User portals

ISO 9001 Standards

Qualityze Suite

SREV Future State with Qualityze EQMS fully Integrated Model

Ops

Sales

Quality Team

Analyze data and triggers for quality. Find positive and negative trends

Develop concise and specific action plans. Correct deficiencies and share best practices

Distribute information to appropriate owners expediently and efficiently

Objectives with Metrics

Feedback to and from customer

Optimize 6 sigma & ISO process and adherence

Training & Coaching

Align Quality to Customer

BI / Command Center Reporting & Integration Services

Data Mgt /

KB

Quality IncidentsRoot Causes/Action Plans

Controlled DocumentsChange ControlTraining Records

AuditsSupplier Quality

Managed Process

NC Mgt

CAPA

Supplier Quality

Change Mgt

Document Mgt

Training Mgt

Customer Complaints

Audit Mgt

SREV Quality Framework with EQMS Future State Benefits Increase Customer Satisfaction by reducing Customer quality issues and audits

• SREV Quality Framework with integrated Qualityze EQMS • Based on Salesforce Platform and Salesforce Integration capabilities

Makes internal operations more efficient and effective. Facilitate seamless operations without business disruption Employees become more responsive to customer needs and requirements Encourages self assessment and maintains internal consistency Complete managed process for quality defect tracking & root cause analysis Provides a universal approach to quality and business

• Controlled process and establishes operational controls Creates awareness for the need of training and encourage operational problem solving skills Total Quality Data in one system with Salesforce Analytics for Reporting Integrated Audit system with quality data for effective data analysis Enforce employee training on controlled documents for compliance requirements Seamless integration to all EQMS quality practices and integration services to external systems Best in class EQMS with intuitive interface for quick user adoption Administrable and Configurable through Qualityze Quality Central

All of the above EQMS benefits transforms your quality into a decision making engine.

Questions and Next Steps

Questions Next Steps to Consider

Quality Center of Excellence Continue to build on the strength and results of the Quality Framework Continue building best in class Quality Organization to help drive high customer satisfaction and effective organization

*Gartner states average business process maintains 3.5 sigma value resulting in data quality effecting overall labor productivity by as much as 20% (*Gartner Measuring the Business Value of Data Quality)

Quality Process Workshop Onsite in Nashville Current State and Future State analysis Action Plan from workshop Implement the next steps

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Speak with our Quality Experts today!

www.Qualityze.com

Optimize Your Quality Systems

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Thank You

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