Stratesys - eDMS Solution OpenText - Flyer+Ebers (USA) - JUNIO2016

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
ebersby

2. GUÍAS DE FABRICACIÓN
Features
Regulatory Compliance
Return on Investment
Added Value Apps
Efficient and compliant Standard Operating Procedure (SOP) and regulated documentation
management is essential for highly regulated industries to maintain the highest level of quality in
every facet of their operations, while at the same time reducing costs and maintaining margins
SOP guidelines are a set of best practices that contribute to operations within a company’s quality control
and quality assurance goals and standards.
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.
SOP Management enables an organization to:
The Stratesys SOP Solution brings together market best-practices and best of breed technology to
automate and better monitor critical business processes for chemical, pharmaceutical, medical device
and biotechnology industries. This modular solution covers the full SOP lifecycle and regulated
documentation management from initial creation to employee training, allowing the QA department a
360º view of its processes within the organization.
Comply with market regulations (i.e.: FDA*)
Optimize productivity
Reduce operation costs
Ensure quality of production
Automated version control
Automated notification and
distribution
Automated review and approval
Template management
Content comparison
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
Stratesys has
developed a solution,
aimed to:
Lotus Notes Migration Tool
Out of Office Report
Audit Trail Report
Validation Services
Training Certificate Report
Integration with SAP BO
FTE REDUCTION Savings in paper eliminationIMPROVEMENT in Productivity Savings on IT system TCO
ebersby
eDMS (Electronic Document
Management System):
SOP and regulated
documentation management.
Seamlessly comply with
GxP** practices
Simplify the process of SOP
and regulated documentation
management
Automate the review and
approval process
Keep all the content in a
controlled and secure
platform
Manage security and content
access based on standard
business roles
Retain an audit trail of the
entire SOP lifecycle
This solution:
Ensures regulatory compliance
Enhances efficiency reducing
cost per SOP
Boosts productivity
Reduces IT TCO
*FDA = Food & Drug Administration **GxP = Good Practice in quality guidelines, rules and regulations
The solution has 3 integrated modules
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
edms SOLUTIOn Content in context to work
eDMS

3. ebersby
eDMS (Electronic Document Management System):
SOP and regulated documentation management.eDMS
SOP Management - Process Flow
Predefined Document Templates
Watermark
Controlled Printing
Active Document Folder
Document previous versions
Predefined Metadata
Predefined user roles
Predefined workflow
HR Integration
Current document
with “EFFECTIVE” StatusApproving date assigned
Edit
Create
Consume
Review
Authorize
Approve
Retire
Initiate Create /
Activate a Review
Revise
Collaborative
Review
Electronic
Sign-off
Review
history
Workflow Coordinator
Authorizer
Auto
Promote
Editor
Approver
Controlled
Periodic Review
Archive
Consumer
FABRICATION
GUIDES
MODULE
TRAINING
MODULE