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