Compliance-in-a-Box™
Impact Systems, Inc.
Partner:
:
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Presentation Outline
1. Compliance-in-a-Box™• Why Compliance-in-a-Box was developed • Compliance-in-a-Box overview and philosophy
2. Compliance-in-a-Box SOP Edition
3. Compliance-in-a-Box Submission Edition
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Why?
We heard our customers
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Compliance-in-a-Box™ (CiB)
• Developed specifically to provide an ECM solution for regulated industries in the SMB market, or departments within larger enterprises
• Enterprise content application – jump start ECM with CiB building blocks
• Cost effective, rapid deployment• Methodology based on industry
experience
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Compliance-in-a-Box™ Philosophy
• Rapid deployment: ready for Production in less than 4 weeks
• Pre-configured, templated solution• Tightly defined project scope and set
of configurations
• Visible, measurable results in a condensed time frame• Embraces Six Sigma principles
(small project with visible and measurable results which lends to continuous improvement)
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Compliance-in-a-Box™ Philosophy
• Significantly reduced implementation cost with minimal IT involvement
• A scalable application across theenterprise, including geographies
It’s not about technology but successful organizational adoption of technology
Enterprise
What is included in the CiB Offering?
Flexibility to Select Single or Multiple Components
Implementation Services(Configuration Parameters, Validation Framework Templates,
Implementation Check List and Project Plan)
Software Specifications
Hardware Specifications
CiB Implementation Services Approach
Engagement completed in < 30 days
Start End
Implementation Project Plan and Check List
Configuration Parameters +1x use of Configuration Tools
Validation FrameworkTemplates
Best Practice”ImplementationMethodology
A completeset of Validation Documentation ready for sign-off
“Go Live” ReadyImplementation
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CiB Delivery Options
Purchased Hardware:• Servers pre built and delivered to
the customer site• Customer manages and maintains
Customer’s Hardware:• Tools and ‘Best Practices’ brought to customer• Servers built on customer infrastructure
Compliance-in-a-Box
Compliance-in-a-Box™ SOP Edition
Partner:
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Challenges
• Versioning • Security model• Review and approval routing• Regulatory agency compliance• Proven, repeatable process
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Enterprise Elements: Life Sciences example
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Typical CiB Engagement
• Requirements Definition• Software Installation• Configuration• Validation• ‘Box’ Delivery• Knowledge Transfer• Project Acceptance & Closure
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Compliance-in-a-Box™ in Use
An International Health Research Institute
• Challenge: The client was in the process of deploying a completely new facility, and needed a way to manage SOPs across the organization. A limited budget was available to accomplish this.
• Solution: The CiB solution was delivered, installed, configured, validated and ready for training in less than four weeks. The customer is planning a phased deployment of EMC Documentum applications. Having CiB in such a short time allowed them to include a system in their design that allows their users a head start in their Documentum Compliance Manager learning curve.
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Compliance-in-a-Box™ in Use
An International Engineering/Construction Management Company
• Challenge: Evolve from home-grown systems and paper processes to an enterprise application for a very large government project.
• Solution: A fully functional, validated, content-ready Documentum Compliance environment was up and running within weeks, providing the customer with a scaleable enterprise application. The CiB solution provided peace of mind that the most recent versions of critical procedures are being adopted and followed immediately, hence reducing risk. Procedural approval times were dramatically reduced from three to five weeks down to one week.
Compliance-in-a-Box™ Submission Edition
Partner:
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Challenges
• Regulatory agency/eCTD compliance
• Shorten drug development timelines
• Getting content under control• Legacy content/legal risk• Proven, repeatable process
Discovery & Research Preclinical Clinical Manufacturing Sales, Marketing
& Service
Process Examples• Toxicology Study
Planning• Resource Allocation
Content Examples• Toxicology Reports• Study Definitions• Analysis & Findings• IND Submissions
Process Examples• Batch Content Mgnt• Structured Product
Labeling - PIM• CAPA• SOP Management
Content Examples• GMP Manufacturing
& Quality Mgnt• Labeling
Process Examples• Contracts Mgnt• Marketing Resource
Mgnt• Web Content Mgnt
Content Examples• Promo Materials• Packaging• Web Site Content
Process Examples• R&D Collaboration• Formulation Mgnt• Protocol / Methods
Management
Content Examples• Disease Condition
Research• Lead Compounds
Process Examples• eTrial Master File• Studies Management• eCase Report Form• eCTD – Regulatory
Submissions
Content Examples• Clin Study Reports• NDA Submission• Study Tagging Files• Trial Materials• Trial Results
Everything must be documented and almost everything must be published
• As of January 1, 2008, companies filing electronic submissions with the U.S. FDA (Food and Drug Administration) must use eCTD format.
• The EMEA (European Medicines Agency) and several individual member health authorities have made similar claims. All member state authorities are expected to accept eCTD by 2009.
Enter the eCTD – Electronic Common Technical Document: International Standard for Submissions to Regulatory Agencies
Challenges with the eCTD
• The eCTD is complex.• The eCTD will drive internal process change.• Electronic document management and eCTD submissions
are often treated as completely separate processes.• Technology solutions - content management and electronic
submission systems - historically have been too expensive for Tier II and Tier III Life Sciences companies.
eCTD Business Impact
• Increased time to market• Inefficient, high cost processes• Increased risk of non-compliance• Increased risk of litigation
The Solution?
• Compliance-in-a-Box Submission Edition
• Best of Breed Solution Set from EMC, ISI and Impact Systems
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What is included in the CiB SE offering?
Documentum Compliance Manager (DCM)
+
Leading Regulatory Submission and Publishing Tools from ISI
+ Pre-configurations, documentation templates,
validation scripts and implementation services from Impact Systems
Process Templates, Pre-configuration Tools and Best Practices for Optimized Deployment
Compliance Interface
Process Services
Content Services
Repository Services
Documentum Compliance
Manager
Virtual Link Manager
EMC Documentum Platform
ISIPublisher
eCTDXPress
Compliance-in-a-Box Submission Edition
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In Summary: CiB Highlight of Features
• Rapid deployment• Hardware and software come fully
validated ready for content• Includes FDA/OQ reports, optional PQ with
training on request
• Allows for easy upgrades and add-ons• Provides an infrastructure that can scale as your organization
grows
• Additional solution features• Includes a wide range of additional features, available
customizations, services and software tools
• Requires less money up front• Create a monthly payment plan over an extended period
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Why CiB?
• Best in class: developed jointly by EMC® Documentum and Impact Systems
• Flexible building blocks to accommodate your needs and priorities:• SOP, submissions, batch records,
CAPA, forms, labels, etc.
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Why Impact Systems?
• 6 years as an EMC Documentum Select Services Partner
• 11 years ECM experience• Comprehensive deployment and
migration experience• Proprietary software tools
• Q-Config™: Configuration deployment, management and migration software
• Q-Transfer™: Bulk data content transfer software• Q-Scripts™: System validation framework
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Thank you for your time.
For More Information:
www.impactinfosys.com
302.573.6864 x105