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Business Goals | KPIs Analysis
QA-CAPA Solution
“The purpose of a Corrective Action and Preventive Action (CAPA) management system is to
identify and investigate existing and potential product and quality problems and assure that
the appropriate, effective and comprehensive actions are taken to solve them."
Non Compliance
DissatisfactionNon-Conformances
Business Content in Business Context
Value Proposition | Return On Investment
• Common Master Data
• Leverage of existing user applications
• Reduction of roll-out time (quick user acceptance)
• Leverage of existing IT Infrastructure
TCOEfficiency
• Elimination of paper based forms
• Elimination of content copies between process participants
• Control of digital content attached to the process
• Minimization of email based communication
Functional Scope
Customers
Employees
QA Users
• Discussions
• Documents
• Tasks
• Reports
• Workflows
Collaboration
Participants
Non
conformity
Case
Resolved
Creation
Quality
Review
Actions &
Assignments
Overview &
Close
Claim
Stratesys has developed a
solution, aimed to:
• simplify the creation of
a claim or non conformity
• dynamically allocate the
needed resources for each
process
• keep the audit trail of the
analysis & resolution
collaborative process
between the QA team and
the participants involved
• keep all the information in
a controlled and secure
platform
• manage a configurable
Quality KPI dashboard
This solution:
• Enhances efficiency
reducing cost per process
• Boosts productivity
• Reduces IT TCO
Productivity
• Automatic traceability and KPI management (excel)
• Robust cross-platform classification criteria
• Template based solution (automates re-use)
• Simple GUI for task creation (dynamic workflow automation)
• Compliant with QA Norms and Regulations
• Secure access to data and content
Every company in every industry that deals with customers and with manufacturing processes
needs a robust system to manage claims and/or non conformities standard operating
procedures to, among other things:
• Minimize customer dissatisfaction
• Comply with QA market regulations
Both processes involve a lot of information sharing, cross-enterprise collaboration and
evidence audit and traceability. Most organizations are currently managing them using paper,
email, complex worksheets and/or departmental applications that are completely
disconnected with the corporate information management systems.
• Eliminate the risk of expensive fines
• Control the total production costs
Stratesys QA-CAPA brings together market best-practices and best of breed technology to
automate and better monitor this critical business processes. Our solution focuses on
simplifying and accelerating the systematic investigation of the root causes of a claim or non
conformity, delivering an added value solution to any Quality Management System (QMS)
compliant with good manufacturing practices (GMP).
QA-CAPA Solution
Process Flow
Creation
Quality Review
Actions & Assignments
Overview
& Close
Customers and/or employees create a
Non Conformity or a Claim and
QA Managers are notified via:
• e-mail
• Assignments Area (Intranet)
Intranet User
Personal Area
Intranet user
Web Based Forms
Quality user
NC and Claims
Review
Overview
Processes
• Check that all actions have been fulfilled
• Include additional information
(total costs, recovery costs and
average closing days)
• Close
• Quality Manager review and approval
• Inform all participants of closed case
• Product and Customer
• Agents involved
• Documents
• Mails
Quality user
NC and Claims
Classification
• Importance
• Reasons
• Immediate cause
• Root cause
Quality user
Define and Assign
Tasks
Collaborative
Tools
• Discussions
• Documents
• Tasks
• Reports
• Workflows
• Task’s name
• Who it is assigned to
• Participants
• Date, Due Date,
Priorities, Milestones,
Instructions, Contents,
Attachments, Categories
User Task
QA User Request
Reject
Cancellation
Inform Intranet Users
Approve
List of User
Non Conformities
Task and
Assignments
Phases /
Milestones
Classification
Claim
Business
Information
Standardized Folder
Structures with all
Related Content
Roles and Users
Assigned
Attachments
List of
User Claims
Business
Information
We develop IT services implementing
OpenText Solutions in several industries
Stratesys is a SAP Service Partner specialized in delivery services
for the following SAP Solution Extensions by OpenText:
Our Partnership with OpenText
Stratesys is a Select Partner of the OpenText
Partner Program for SAP Competence. This
status recognizes Stratesys as experts in the
delivery of OpenText ECM for SAP solutions to
its customers. With this membership, Stratesys
is committed to maintain up-to-date knowledge
through on-going training, certification and
blended delivery of services.
In Stratesys we have a deep understanding and
wide experience in OpenText products that
integrate with our clients SAP software
landscape. Our expertise in design-definition,
implementation and support, combined with a
specific understanding of vertical requirements
such as eCTD and Contract Management, self-
service vendor, places Stratesys as one of the
major players in project execution in this
technology.
Core Services
Implementation
AM
Document
Analysis
Change
Management
Model
Definition
Public Sector,
Health &
Education
Telecom &
Media
Manufacturing
Construction &
Real Estate
Energy &
Utilities
Retail
Transportation
Life Sciences
Banking &
Insurance
Consume
Goods
SAP Document
Access by OpenText
SAP Extended ECM
by OpenText
SAP Digital Asset
Management by
OpenText
SAP Document Presentment
by OpenText
SAP Invoice
Management
by OpenText
OCR Option for SAP Invoice
Management by OpenText
SAP Employee File
Management by OpenText SAP Archiving by OpenText
Copyright Stratesys Technology Solutions SL. All rights reserved.
No part of this document may be reproduced or transmitted by any means, for any purpose without the express
permission of Stratesys. All products are trademarks or registered trademarks of their respective companies.
info@stratesys-ts.com
B R A Z I L | C H I N A | C O L O M B I A | M E X I C O | P O R T U G A L | S P A I N | U S A
www.stratesys-ts.com @stratesys
With the OpenText Partner Program for SAP
Competence, OpenText relies on partners that clearly
differentiate themselves through deep technical SAP
expertise from other service providers and consulting
firms in the market. SAP Competence partners are highly
committed, innovative, and growth-oriented companies
with excellent project, industry, and process knowledge.
FRV
Click on the
pictures to learn
more about our
OpenText customer
success stories
COBEGA
Leaders in
SAP & OpenText Technology
Innovators and Specialists

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Stratesys - Flyer QA-CAPA - ENG2014

  • 1. Business Goals | KPIs Analysis QA-CAPA Solution “The purpose of a Corrective Action and Preventive Action (CAPA) management system is to identify and investigate existing and potential product and quality problems and assure that the appropriate, effective and comprehensive actions are taken to solve them." Non Compliance DissatisfactionNon-Conformances Business Content in Business Context Value Proposition | Return On Investment • Common Master Data • Leverage of existing user applications • Reduction of roll-out time (quick user acceptance) • Leverage of existing IT Infrastructure TCOEfficiency • Elimination of paper based forms • Elimination of content copies between process participants • Control of digital content attached to the process • Minimization of email based communication Functional Scope Customers Employees QA Users • Discussions • Documents • Tasks • Reports • Workflows Collaboration Participants Non conformity Case Resolved Creation Quality Review Actions & Assignments Overview & Close Claim Stratesys has developed a solution, aimed to: • simplify the creation of a claim or non conformity • dynamically allocate the needed resources for each process • keep the audit trail of the analysis & resolution collaborative process between the QA team and the participants involved • keep all the information in a controlled and secure platform • manage a configurable Quality KPI dashboard This solution: • Enhances efficiency reducing cost per process • Boosts productivity • Reduces IT TCO Productivity • Automatic traceability and KPI management (excel) • Robust cross-platform classification criteria • Template based solution (automates re-use) • Simple GUI for task creation (dynamic workflow automation) • Compliant with QA Norms and Regulations • Secure access to data and content Every company in every industry that deals with customers and with manufacturing processes needs a robust system to manage claims and/or non conformities standard operating procedures to, among other things: • Minimize customer dissatisfaction • Comply with QA market regulations Both processes involve a lot of information sharing, cross-enterprise collaboration and evidence audit and traceability. Most organizations are currently managing them using paper, email, complex worksheets and/or departmental applications that are completely disconnected with the corporate information management systems. • Eliminate the risk of expensive fines • Control the total production costs Stratesys QA-CAPA brings together market best-practices and best of breed technology to automate and better monitor this critical business processes. Our solution focuses on simplifying and accelerating the systematic investigation of the root causes of a claim or non conformity, delivering an added value solution to any Quality Management System (QMS) compliant with good manufacturing practices (GMP).
  • 2. QA-CAPA Solution Process Flow Creation Quality Review Actions & Assignments Overview & Close Customers and/or employees create a Non Conformity or a Claim and QA Managers are notified via: • e-mail • Assignments Area (Intranet) Intranet User Personal Area Intranet user Web Based Forms Quality user NC and Claims Review Overview Processes • Check that all actions have been fulfilled • Include additional information (total costs, recovery costs and average closing days) • Close • Quality Manager review and approval • Inform all participants of closed case • Product and Customer • Agents involved • Documents • Mails Quality user NC and Claims Classification • Importance • Reasons • Immediate cause • Root cause Quality user Define and Assign Tasks Collaborative Tools • Discussions • Documents • Tasks • Reports • Workflows • Task’s name • Who it is assigned to • Participants • Date, Due Date, Priorities, Milestones, Instructions, Contents, Attachments, Categories User Task QA User Request Reject Cancellation Inform Intranet Users Approve List of User Non Conformities Task and Assignments Phases / Milestones Classification Claim Business Information Standardized Folder Structures with all Related Content Roles and Users Assigned Attachments List of User Claims Business Information
  • 3. We develop IT services implementing OpenText Solutions in several industries Stratesys is a SAP Service Partner specialized in delivery services for the following SAP Solution Extensions by OpenText: Our Partnership with OpenText Stratesys is a Select Partner of the OpenText Partner Program for SAP Competence. This status recognizes Stratesys as experts in the delivery of OpenText ECM for SAP solutions to its customers. With this membership, Stratesys is committed to maintain up-to-date knowledge through on-going training, certification and blended delivery of services. In Stratesys we have a deep understanding and wide experience in OpenText products that integrate with our clients SAP software landscape. Our expertise in design-definition, implementation and support, combined with a specific understanding of vertical requirements such as eCTD and Contract Management, self- service vendor, places Stratesys as one of the major players in project execution in this technology. Core Services Implementation AM Document Analysis Change Management Model Definition Public Sector, Health & Education Telecom & Media Manufacturing Construction & Real Estate Energy & Utilities Retail Transportation Life Sciences Banking & Insurance Consume Goods SAP Document Access by OpenText SAP Extended ECM by OpenText SAP Digital Asset Management by OpenText SAP Document Presentment by OpenText SAP Invoice Management by OpenText OCR Option for SAP Invoice Management by OpenText SAP Employee File Management by OpenText SAP Archiving by OpenText Copyright Stratesys Technology Solutions SL. All rights reserved. No part of this document may be reproduced or transmitted by any means, for any purpose without the express permission of Stratesys. All products are trademarks or registered trademarks of their respective companies. info@stratesys-ts.com B R A Z I L | C H I N A | C O L O M B I A | M E X I C O | P O R T U G A L | S P A I N | U S A www.stratesys-ts.com @stratesys With the OpenText Partner Program for SAP Competence, OpenText relies on partners that clearly differentiate themselves through deep technical SAP expertise from other service providers and consulting firms in the market. SAP Competence partners are highly committed, innovative, and growth-oriented companies with excellent project, industry, and process knowledge. FRV Click on the pictures to learn more about our OpenText customer success stories COBEGA Leaders in SAP & OpenText Technology Innovators and Specialists