The document describes a global solution for managing documents and processes for pharmaceutical companies called Stratesys QA-CAPA. It provides a corrective and preventive action (CAPA) management system that simplifies the identification, management, and closure of customer claims and non-conformities. The solution brings together best practices and technology to automate and monitor these critical business processes. It aims to significantly reduce customer complaints, minimize financial risks of non-compliance, and maintain compliance with quality and market regulations.

1. Global solution for managing documents and processes of
pharmaceutical companies built on Extended ECM by OpenText.
Accesible from any device by an HTML5
simplified and role-based user interface.
CAPA
CAPA
Corrective And
Preventive Action
Claim and
Non-Conformity
identification,
management
and closure
eTMF
Electronic Trial
Master File
Clinical trials
documentation
management
eDMS
Electronic Document
Management System
SOP and regulated
documentation
management
eCTD
Electronic Common
Technical Document
Administrative
documentation for
registration of
pharmaceuticals for
human use
BRAZIL | CHINA | COLOMBIA | MEXICO | PORTUGAL | SPAIN | USA
www.stratesys-ts.com
eTMF eDMS eCTD
a new concept
of LIFE SCIENCE
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2. Functional Scope
QA-CAPA Solution Business Content
in Business Context
Value Proposition| Return On Investment Business Goals | KPIs Analysis
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 appropriate, effective and comprehensive actions are taken to solve them.
Companies in every industry require robust systems to manage two key processes: (1) Their customer
claims and (2) Non-conformities to standard operating procedures to achieve, among other things:
Both processes require seamless information sharing, cross-enterprise collaboration, and audit evidence
traceability. Despite the critical nature of these areas, most companies address them with paper-based
processes, email, spreadsheets, or non-integrated and departmentally focused applications. These
“solutions” are also typically not integrated with the companies’ core information management systems,
causing more inefficiencies and lack of visibility.
The Stratesys QA-CAPA solution brings together market best-practices and best of breed technology
to automate and better monitor these critical business processes. Our solution focuses on simplifying
and accelerating the systematic investigation of the root causes of a customer claim or non-conformity,
delivering a value added solution to any Quality Management System (QMS) and support compliance
with good manufacturing practices (GMP).
Significant reductions in customer complaints
Minimize financial risks associated with
non-compliance and fines
Compliance with QA and market regulations
Maintain detailed control over production
costs
Stratesys
has developed a solution
that achieves the following:
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CAPA
(Corrective and
Preventive Action)CAPA
Simplifies the creation of a
customer claim or process
non-conformity
Dynamically allocates
resources required for each
process
Keeps an audit trail of the
collaborative process analysis
and resolution of CAPA
between the QA team and all
involved participants
Stores all relevant information
on a controlled and secure
platform
Provides a configurable
dashboard to follow Quality KPI
Enhances efficiency by
reducing process costs
Provides an integrated process
view and enhanced
management visibility
Boosts Quality Team
productivity
Reduces IT TCO
Value Proposition| Return On InvestmentReturn On Investment Business Goals | KPIs AnalysisReturn On Investment Business Goals | KPIs AnalysisBusiness Goals | KPIs Analysis
Efficiency
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
TCO
Common Master Data
Leverage existing user applications
Reduction of roll-out time (quick user acceptance)
Leverage of existing IT Infrastructure
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
CREATION QUALITY REVIEW ACTIONS & ASSIGNMENTS OVERVIEW & CLOSE
Customers
Employees
QA
Users
Participants
Case
Resolved
Discussions
Documents
Tasks
Reports
Workflows
CLAIM COMMUNICATION
COLLABORATION
Non-Conformity Customers
Employees

3. e-mail
Assignments Area (Intranet)
Product and Customer
Agents involved
Documents
Mails
Importance
Reasons
Immediate cause
Root cause
Task’s name
Who it is assigned to
Participants
Date, Due Date, Priorities,
Milestones, Instructions,
Contents, Attachments,
Categories
Discussions
Documents
Tasks
Reports
Workflows
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
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CAPA
(Corrective and Preventive Action)CAPA
QA-CAPA Solution - Process Flow
Quality Review
Cancellation
Inform Intranet Users
Creation
Actions & Assignments
Overview
& Close
Customers and/or employees
create a Non-Conformity or a Claim
and QA Managers are notified via:
Intranet user
Web Based Forms
Approve
Overview
Processes
Reject
Intranet User
Personal Area
Quality user
NC and Claims
Review
Collaborative
Tools
Quality user
NC and Claims
Classification
Quality user
Define and
Assign Tasks
Non-Conformity
Claim
Business Information Attachments
List of User
Non Conformities
List of
User Claims
User Task
QA User Request
Importance
Task and Assignments
Classification
Business InformationStandardized Folder Structures
with all Related Content
Roles and Users AssignedPhases / Milestones