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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GUÍAS DE FABRICACIÓN

FeaturesRegulatory 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 costsEnsure quality of production

Automated version controlAutomated notification and distributionAutomated review and approvalTemplate managementContent comparisonComplies with FDA 21CFR Part 11 for electronic document management

Search FunctionalityContent and metadata searchUser defined saved searches

SecurityRole based access to contentAuditability and traceability of the processControlled printingWatermarking 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

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eDMS (Electronic Document Management System):SOP and regulated documentation management.

Seamlessly comply withGxP** 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 HREmployee skill and work role ManagementRegister of SOP training Management of External TrainingGeneration of Skills Certificate

CreationRevisionApprovalPublishing and DistributionReviewArchiving

Integrated with SAP manufacturing processControlled printing of guides and master documentChange of state workflowDeviation management

edms SOLUTIOn Content in context to work

eDMS

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eDMS (Electronic Document Management System):SOP and regulated documentation management.

eDMS

SOP Management - Process Flow

Predefined Document Templates

WatermarkControlled Printing

Active Document Folder

Document previous versions

Predefined Metadata

Predefined user roles

Predefined workflow

HR Integration

Current documentwith “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

FABRICATIONGUIDES

MODULE

TRAINING MODULE