Global solution for managing documents and processes of pharmaceutical companies built on Extended ECM by OpenText.

Accesible from any device by an HTML5simplified and role-based user interface.

CAPA

CAPACorrective And

Preventive ActionClaim and

Non-Conformity identification, managementand closure

eTMFElectronic Trial

Master FileClinical trials

documentation management

eDMSElectronic Document Management System

SOP and regulated documentation management

eCTDElectronic Common Technical Document

Administrative documentation for

registration of pharmaceuticals for

human use

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

eTMF eDMS eCTD

a new conceptof LIFE SCIENCE

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Functional Scope

QA-CAPA Solution Business Contentin 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 complaintsMinimize financial risks associated with non-compliance and fines

Compliance with QA and market regulationsMaintain detailed control over production costs

Stratesyshas 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 Investment Return On Investment Business Goals | KPIs AnalysisReturn On Investment Business Goals | KPIs AnalysisBusiness Goals | KPIs Analysis

Effic

ienc

y Elimination of paper based formsElimination of content copies between process participantsControl of digital content attached to the processMinimization 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

Prod

ucti

vity

Automatic traceability and KPI management (excel)Robust cross-platform classification criteriaTemplate based solution (automates re-use)Simple GUI for task creation (dynamic workflow automation)Compliant with QA Norms and RegulationsSecure access to data and content

CREATION QUALITY REVIEW ACTIONS & ASSIGNMENTS OVERVIEW & CLOSE

CustomersEmployees

QAUsers

Participants

CaseResolved

DiscussionsDocumentsTasksReportsWorkflows

CLAIM COMMUNICATIONCOLLABORATION

Non-Conformity CustomersEmployees

e-mailAssignments Area (Intranet)

Product and CustomerAgents involvedDocumentsMails

ImportanceReasonsImmediate causeRoot cause

Task’s nameWho it is assigned toParticipantsDate, Due Date, Priorities, Milestones, Instructions, Contents, Attachments, Categories

DiscussionsDocumentsTasksReportsWorkflows

Check that all actions have been fulfilledInclude additional information(total costs, recovery costs andaverage closing days)CloseQuality 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

CancellationInform 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 userWeb Based Forms

Approve

Overview Processes

Reject

Intranet UserPersonal Area

Quality userNC and Claims Review

CollaborativeTools

Quality userNC and Claims

Classification

Quality userDefine and

Assign Tasks

Non-ConformityClaim

Business Information Attachments

List of User Non Conformities

List ofUser Claims

User TaskQA User Request

Importance

Task and Assignments

Classification

Business InformationStandardized Folder Structureswith all Related Content

Roles and Users Assigned Phases / Milestones