STR-PRES - EBERS Electronic QMS Solution Powered by OpenText - JUN 2016

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Electronic QMS Solution
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Stratesys, your Partner of Trust
QA EDMS Solution Demo Session (30 min)
eCTD Solution Demo Session (15 min)
eTMF Solution Demo Session (20 min)
CAPA Solution Demo Session (20 min)

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Stratesys, your Partner of Trust

About Stratesys
Global IT Services Provider
4
Stratesys is leader in IT Services and specialist in different technologies with
over 18 years of experience in the market. Credited with a high level of
specialization, developing business solutions and technological applications
for clients.
We can help you define, implement and develop your SAP strategies
by utilizing our innovative proven methodologies.
revenue growth in the
last 5 years
active clients
in all industries
countries with local
presence (offices and
centers of expertise)
SAP implementation
projects
skilled
professionals
US$ 42M+ 100%+
200+ 7
800+ 700
Leaders in
SAP Technology
Expert
Knowledge
Industry
Expertise
Software
Solutions
IT Strategy
Quality
Assurance

About Stratesys Recognized and distinguished within the SAP Ecosystem
Leaders in SAP Technology
5
2nd
POSITION
in April 2016 SAP Ranking of
SAP Services Partners (Spain)
76
SAP certifications in cross
and industry solutions
40
success stories developed
during the last 5 years
Stratesys is one of the largest SAP specialist firms in the industry. In April 2016 SAP once again recognized
our expertise in their annual ranking as one of their service partners leaders in Spain (2nd),
certifying us as experts in 76 solutions (cross and industry) in their portfolio.

About Stratesys
Leaders in OpenText Technology
6
Stratesys is recognized as experts in the delivery of OpenText solutions to its customers.
Our deep understanding and wide experience in OpenText products that integrate with our
clients SAP and non-SAP software landscape, allows us to deliver Enterprise Information
Management value added projects. Our expertise in design-definition, implementation and
support, combined with a specific understanding of vertical requirements for vertical
markets like Life Science or Construction & Engineering, positions us as one of the major
players in project execution in this technology.
Stratesys is committed to maintain up-to-date knowledge through on-going training,
certification and blended delivery of services, leveraging our OpenText Center of
Excellence, to demonstrate our experience and capabilities of all OpenText solutions.
Our Partnership with Why Stratesys
Stratesys is an OpenText
reference technology partner.
We are the first company in
Spain to obtain official ranking
of SAP Competence Partner.
Stratesys was the inaugural
OpenText Partner Spotlight
EMEA winner in Spain.
Our OpenText Figures
Skilled
Team
70
Projects
150+
Success
Stories
15+
Certified in
ALL SAP by
OpenText Solutions
10
Active
clients
60+
Certified
Solutions in
OpenText Catalog
5
We cover the whole OpenText Portfolio
[…]
[Commerce]
[CRM]
[HR][EAM]
[ERP]
2004
2008
2011

About Stratesys
Experts in Life Sciences Industry
7
Stratesys has a deep understanding of the latest
tendencies affecting the pharmaceutical industry in
general, as well as its relationship with every player
in the ecosystem. Our portfolio in this industry
includes planning solutions, execution and
documentation of every moment in the life cycle of a
drug or pharmaceutical product, bearing in mind the
distinctive features of product research and
development, production, sales and supply, as well as
finances and regulations.
Services & Solutions Portfolio
 Supply chain planning: demand planning,
supply chain planning.
 ERP design and implementation on SAP
platform.
 ECM strategy definition and product selection
 Supply chain implementation and integration
for third parties: clients, providers, logistics
operators, monitoring.
 Content and document processing tools.
CTD/eCTD, in accordance with 21 CFR part 11.
 Workforce mobility
 Interfaces with LIMS systems, electronic batch
records
 Product Safety: Incident Report and CAPA.
 Corporate Functions: Debt and Integrated
Interests scam Documental Management.
Budgeting and Consolidation. Account
Analytical Results.
 Control Panels and Business Intelligence
Dashboards
 Implementation of Advanced Management
solutions for purchasing and contracting
 GxP regulated production. As per GMP and FDA
 Talent Management and 360º evaluation
 AM and BPO Payroll Services
Our Pharma Industry Figures
Industry Experts
20 Active clients
20+
Projects
75 Official
Success Stories
3
Industry Recognition
Specific Pharma Solutions
Global solution for managing documents and processes of
pharmaceutical companies built on Extended ECM by OpenText.
SAP Advanced
Track & Trace

About Stratesys
Life Science Customers
(ECM)
Our Capabilities
Experts in Pharma Industry
8
Our References – ERP & ECM Customers
(ERP / BI / HCM)
(ERP / BI / HCM / ECM)

About Stratesys Our clients are leaders in their respective industries
Delivering Solutions Across all Industries
9
Energy &
Utilities
Telecom &
Media
Manufacturing
Public Sector,
Health &
Education
Construction &
Real Estate
Consumer
Goods
Retail
Transportation
Life Sciences
Banking &
Insurance

About Stratesys Where our clients need us
Global Presence - Local Support
10
Projects
Offices
Our network of offices and specialized Centers of
Excellence offer coverage to different
geographies and markets where we operate. Our
international presence spans Europe, USA, Latin
America and Asia Pacific.
Madrid
Barcelona
Valencia
Oviedo
Seville
Coruña
São Paulo Shanghai
Brazil Spain
Palo Alto
USA
China
Armenia
Bogotá
Colombia
Lisbon
Portugal
México DF
Mexico
60+ countries
Projects in
We execute multiple implementation and
roll-out information systems projects
in more than 60 countries.

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QA EDMS Solution Demo Session (30 min)
 QA EDMS Solution Overview
 QA EDMS Solution Demo
 Q&A
QA eDMS

QA eDMS
SOP Management System for OpenText Content Suite
Elements of a pharma QMS
12
CAPA
QA eDMS eCTD CHANGE CONTROL
eTMF

QA eDMS
Business Needs
QA eDMS for OpenText Content Suite
13
In R&D and manufacturing, Standard Operating Procedures (SOPs) define the business
rules and processes for everything from pre-clinical research, clinical development, and
equipment operation to the release of new products.
Industries regulated by the FDA, such as pharmaceutical, medical device, and
biotechnology, SOPs must be strictly managed to assure compliance with current GxP
quality guidelines and regulations.
User roles: 5 for SOP,
3 for Fabrication Guides
and 4 for Training
12
Preconfigured Workflows:
5 for SOP, 8 for Training,
2 for Fabrication Guides
15
Prebuilt Document
types and subtypes
35
Accelerators for Integrations
with SAP HR, SAP PM, SAP BO,
eCTD and Lotus Notes
5
Predefined Business
Units and
Departments
20
Preconfigured
reports and
custom searches
40

QA eDMS
Business Needs
14
TRAINING
SOP MANAGEMENT
FABRICATION GUIDES
 Integrated with SAP HR
 Employee skill and work
role Management
 Register of SOP training
 Management of External
Training
 Generation of Skills
Certificate
 Creation
 Revision
 Approval
 Publishing and
Distribution
 Review
 Archiving
 Integrated with SAP
manufacturing process
 Controlled printing of
guides and master
document
 Change of state workflow
 Deviation management

QA eDMS
Master Metadata
15
Center
Document Types (scopes)
Business Units

QA eDMS
Roles per Center:
<center name> - Read
<center name> - Manage
<center name> - Print
<center name> - QA
<center name> - Retire
Roles per Center:
<center name> - Guide Reader
<center name> - Guide Manager
<center name> - Guide Printer
Roles per Center:
<center name> - Read (Employees)
<center name> - Employee Managers
<center name> - HR
<center name> - QA
Classification & Security
16
TRAININGSOP MANAGEMENT FABRICATION GUIDES
Operative Area
Documents
GDF - Document System Management
Documents
Company
Documents
Center
Documents
Department
Documents
_Guides
Company
Center
Year
Company
Center
_Employees
Company
Center
Operative Area
Department
_Job Function
Company
Center
_Courses

QA eDMS
SOP Management
17
Complete traceability of the SOPs
lifecycle
 Classification Metadata
 Reviews and Approvals
 Existing controlled copies

QA eDMS
SOP Management
18
Advanced Workflows:
 Create SOPs
 Review SOPs
 Create new versions SOPs
 Retire SOPs
eSigning for Tasks

QA eDMS
SOP Management
19
 Controlled copies generation in
PDF or with watermark with a
predetermined printer.
 Non controlled copy printing
with watermarks

QA eDMS
Fabrication Guides
20
Complete workflow for the
fabrication guide:
 Integration with fabrication
order in SAP
 Printing of controlled copies
 Fabrication issues registry

QA eDMS
Training
21
Employee Skill Management:
 Integrated with employee
masterdata
 Job description Management
 Skill Certificate generation
 External and internal Course and
training catalog management

QA eDMS
Solution Summary
22
Content Management
 Automated version control
 Automated notification and distribution
 Automated review and approval
 Template management
 Content comparison
Regulatory Compliance
 Complies with GCP DIA Ref Model
 Complies with FDA 21CFR Part 11 for
electronic document management
Search Functionality
 Content and metadata search
 User defined saved searches
Security
 Role based access to content
 Auditability and traceability of the
process
 Controlled printing
 Watermarking for managing hardcopies
Return on Investment
Savings on SOP time generation Productivity Improvement Savings on paper elimination Savings on IT system TCO
Migration tools (i.e.: Lotus Notes)
Training Certificate Report
eCTD integration
Audit Trail Report
Out of Office Report
Integration with Analytics
(i.e.: SAP BO)
Value Added
Components
Integration with SAP HR

QA eDMS
Solution Demonstration
23
Document Owner Document Reviewer Document Readers
Document Owner Document Owner
Automatic Notification
of Documents to Review
Launch New
Version Process
Document is Reviewed
with Comments
Comments are Accepted
and Document Approved
Automatic Document released
to mandatory readers
STEP 1 STEP 3 STEP 5
STEP 2 STEP 4

QA eDMS
Solution Demonstration
24
SOP Information User Activity Dashboard UI

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eCTD Solution Demo Session (15 min)
 eCTD Solution Overview
 eCTD Solution Demo
 Q&A
eCTD

eCTD
eCTD for OpenText Content Suite
26
CAPA
eTMF

eCTD
Business Needs
eCTD Solution for OpenText Content Suite
27
The Common Technical Document (CTD) is a set of specification for
application dossier for the registration of Medicines and designed to be
used across Europe, Japan and the United States. It is an internationally
agreed format for the preparation of applications regarding new drugs
intended to be submitted to regional regulatory authorities in participating
countries. It was developed by the European Medicines Agency (EMA,
Europe), the Food and Drug Administration (FDA, US) and the Ministry of
Health, Labour and Welfare (Japan).
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsS
ubmissionRequirements/ElectronicSubmissions/ucm330116.htm
http://esubmission.ema.europa.eu/ectd/
http://www.mhlw.go.jp/english/policy/health-
medical/pharmaceuticals/index.html
Sources:
User roles
3
Preconfigured
workflows
2
Sequence management
procedures
2
Accelerators for integration with
Submission platforms (Extedo, Lorenz),
Lotus Notes, Sequence Export
3
eCTD prebuilt
templates
5
Preconfigured
reports
6

eCTD
Business Needs
28
The eCTD is the electronic version of the CTD and the preferred
format for the submission of files and metadata from a submitter
to a receiver. The primary technical components are:
 A high level folder structure
 An XML "backbone" file which provides metadata about
content files and lifecycle instructions for the receiving system
 An optional lower level folder structure
 Associated document type definitions (DTDs) and stylesheets.
Each submission message constitutes one "sequence". A
cumulative eCTD consists of one or more sequences. Each
sequence has 5 modules:
 Module 1: Administrative and prescribing information
(may vary in each location)
 Module 2: Overview and summary of modules 3 to 5
 Module 3: Quality (pharmaceutical documentation)
 Module 4: Preclinical (Pharmacology/Toxicology)
 Module 5: Clinical – efficacy (Clinical Trials)
Regional
Admin
Information
Module1
Quality
Module 3
Nonclinical
Study Reports
Module 4
Clinical
Study Reports
Module 5
Quality
Overall
Summary
Module 2 Nonclinical
Overview
Clinical
Overview
Nonclinical
Summary
Clinical
Summary
Not part
of the CTD
The CTD
The CTD Triangle

eCTD
Classification & Security
29
Roles per Reference:
Regulatory Affairs => Full permission
Pharmaceutical Development => Write
Clinical Development => Write
QA => Read
System Admin
Reference Template Sequence TemplateCTD Management

eCTD
CTD Management
30
CTD Generation:
 Create Reference
 Allocate users for CTD creation
 Manage References
 Automatic Classification

eCTD
CTD Management
31
Advanced Workflows:
 Create New Sequence
 Change Sequence Status
 Export eCTD
 Combine Sequence
eSigning for Tasks

eCTD
Reports
32
Preconfigured usage reports:
 References by Country
 References by Product
 Export to excel

eCTD
eSubmission Integration
33
Content Management:
 Study generation
 Metadata management
 Sequence compilation
 Document edition
 Study closure
 Allocate
 Sequence structure export
(PDF renditions and XML)
 XML
 ZIP (folder structure
with PDF documents)
eSubmission
Software
Supported eCTD
standards:
EU, FDA, CA, CH, JP,
MCC, GCC/KSA
Submission Management:
 Support for MRP/DCP procedures
 Automated eCTD DTD upgrades
 Automated management and
generation of Study Tagging Files
 Support for parallel submissions
 Easy reuse of submissions
 Integrated Validator
 Interim documents for paper publishing
eCTD Generation eCTD Submission

eCTD
eSubmission Integration
34
There is a standard connector between OpenText and Extedo that
provides customers the following “out of the box” functionalities:
 Connect, add / show document
 Check in / Check out
 Check for new version
 Import/Upload from File System
 Search
 Import Submission
 Upload of submissions to the DMS
 Upload of Structured Documents (PIM, SPL, etc.) as ZIP files
 Version View (Tab View)
 Support for virtual documents
 Add custom columns to Add Document dialog
 Support of renditions
This connector is implemented in the customers we show this
slide and is sold by Extedo, therefore is not included in the bid of
materials.

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eTMF Solution Demo Session (20 min)
 eTMF Solution Overview
 eTMF Solution Demo
 Q&A
eTMF

eTMF
eTMF for OpenText Content Suite
36
CAPA
eTMF

eTMF
Business Needs
37
Standard Naming
Based on ICH E6 Sect. 8 &
industry-accepted terminology
Standard Contents
Industry opinion on
what is kept in a TMF
Standard Metadata
For eTMFs, minimum metadata
at system and artifact level
Standard Structure
To support paper and
electronic systems

eTMF
Products
Classification, Security and Masterdata
38
Document
Types (Artifacts)
Roles per Company:
<Company>- Viewer
<Company>- CRO
<Company>- TMF Admin
<Company>- System Admin
eTMF Management
Countries
& Sites
Products
Countries & Sites
Document Types

eTMF
eTMF Management
39
Standard eTMF Template
 TMF Lifecycle Management
 Classification Metadata
 Document Structure
 Default Roles & Permissions
(Writer, External, Viewers)
 Metadata Navigation

eTMF
eTMF Management
40
Advanced Workflows:
 Create eTMF
 Document Approval
 Close eTMF
eSigning for Tasks TMF Work
items

eTMF
eTMF Management
41
Compliance:
 Document audit
 Document Classification
 My Assignments/Tasks

eTMF
Solution Summary
42
Content Management
 TMF Taxonomy
 Template management
 TMF Metadata model
 Content reference between TMF
 TMF closure workflow
Regulatory Compliance
 Complies with GCP DIA Ref Model
 Complies with FDA 21CFR Part 11 for
electronic document management
Search Functionality
 Content and metadata search
 User defined saved searches
 Metadata Navigation
Security
 Role based access to content
 eSignature for approvals
 Auditability and traceability of the
process
Bulk Export
eCTD integration
External Access UI (i.e.: CROs)
Audit Trail Report
Out of Office Report
Integration with Analytics
(i.e.: SAP BO)
Value Added
Components
Return on Investment
Savings on TMF generation Productivity Improvement Savings on paper elimination Savings on IT system TCO

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CAPA Solution Demo Session (20 min)
 CAPA Solution Overview
 CAPA Solution Demo
 Q&A
CAPA

CAPA
QA-CAPA Management System for OpenText Content Suite
44
CAPA
eTMF

CAPA
Business Needs
CAPA MS for OpenText Content Suite
45
CAPA is launched by event - either a laboratory investigation, a manufacturing
inconsistency, a regulatory or internal audit, or a customer complaint.
Corrective action and preventive action (CAPA) are improvements to an
organization's processes taken to eliminate causes of non-conformities or other
undesirable situations.
CAPA is a concept within good manufacturing practice (GMP). It focuses on the
systematic investigation of the root causes of non-conformities in an attempt to
prevent their recurrence (for corrective action) or to prevent occurrence (for
preventive action).
User roles
5
Preconfigured
workflows
3 Accelerators for integration with Portals
(SAP or SharePoint), SAP BO and
customer communication processes
4
Prebuilt templates
(Claims, Non Conformities)
2
preconfigured QA
KPIs Dashboard
20

CAPA
Business Needs
46
Absence of predefined
rules for workflow
automation
Data quality and volume
of information managed
Auditability
managed
manually
Poor of
accessibility
control
Insufficient
traceability
Isolated from
corporate
infrastructure
and data
User reluctancy

CAPA
QA-CAPA Management
47
Corporate
Intranet
Request Case
Claim Form
NC Form
QA
Team
Approve
Claim List
Non Conformity List

CAPA
QA-CAPA Management
48
QA-CAPA UI Collaborative Tools (Discussion, Task)
Case
Participants
QA
Team

CAPA
QA-CAPA Management
49
Closed QA-CAPAClosure Workflow QA Users
Mail to
Participants

CAPA
QA-CAPA Dashboard
50
CAPA Analytics:
 Usage Reports
 CAPA Status Reports
 Quality KPIs with Business Data

www.stratesys-ts.com
@stratesys
Copyright Stratesys Technology Solutions. 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.

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