TrackWise: Enterprise Quality Management-Lösung (EQMS) für die Pharma- und Biotechnologiebranche
Enterprise Quality Management Software - Qualityze EQMS
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Transcript of Enterprise Quality Management Software - Qualityze EQMS
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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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