Compliance In A Box Documentum Deployment Solution

Compliance-in-a-Box™ Impact Systems, Inc. Partner: :

Presentation Outline ,[object Object],[object Object],[object Object],[object Object],[object Object],June 4, 2009 Confidential & Proprietary ImpactInfoSys.com June 4, 2009 Confidential & Proprietary ImpactInfoSys.com

Why? ,[object Object],June 4, 2009 Confidential & Proprietary ImpactInfoSys.com June 4, 2009 Confidential & Proprietary ImpactInfoSys.com

Compliance-in-a-Box™ (CiB) ,[object Object],[object Object],[object Object],[object Object],June 4, 2009 Confidential & Proprietary ImpactInfoSys.com

Compliance-in-a-Box™ Philosophy ,[object Object],[object Object],[object Object],[object Object],[object Object],June 4, 2009 Confidential & Proprietary ImpactInfoSys.com

Compliance-in-a-Box™ Philosophy ,[object Object],[object Object],June 4, 2009 Confidential & Proprietary ImpactInfoSys.com

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 Framework Templates Best Practice” Implementation Methodology A complete set of Validation Documentation ready for sign-off “ Go Live” Ready Implementation

CiB Delivery Options ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],June 4, 2009 Confidential & Proprietary ImpactInfoSys.com

Compliance-in-a-Box™ SOP Edition Partner:

Challenges ,[object Object],[object Object],[object Object],[object Object],[object Object],June 4, 2009 Confidential & Proprietary ImpactInfoSys.com June 4, 2009 Confidential & Proprietary ImpactInfoSys.com

Enterprise Elements: Life Sciences example June 4, 2009 Confidential & Proprietary ImpactInfoSys.com

What is included in the CiB SOP offering? ,[object Object],[object Object],[object Object],[object Object],June 4, 2009 Confidential & Proprietary ImpactInfoSys.com

Typical CiB Engagement ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],June 4, 2009 Confidential & Proprietary ImpactInfoSys.com

Compliance-in-a-Box™ in Use ,[object Object],[object Object],[object Object],June 4, 2009 Confidential & Proprietary ImpactInfoSys.com

Compliance-in-a-Box™ Submission Edition Partner:

Everything must be documented and almost everything must be published Discovery & Research Preclinical Clinical Manufacturing Sales, Marketing & Service ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

[object Object],[object Object],Enter the eCTD – Electronic Common Technical Document: International Standard for Submissions to Regulatory Agencies

Challenges with the eCTD ,[object Object],[object Object],[object Object],[object Object]

eCTD Business Impact ,[object Object],[object Object],[object Object],[object Object]

The Solution? ,[object Object],[object Object]

What is included in the CiB SE offering? ,[object Object],[object Object],[object Object],[object Object],[object Object],June 4, 2009 Confidential & Proprietary ImpactInfoSys.com

Compliance-in-a-Box Submission Edition 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 ISIPublishe r eCTDXPress

In Summary: CiB Highlight of Features ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],June 4, 2009 Confidential & Proprietary ImpactInfoSys.com

Why CiB? ,[object Object],[object Object],[object Object],June 4, 2009 Confidential & Proprietary ImpactInfoSys.com

Why Impact Systems? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],June 4, 2009 Confidential & Proprietary ImpactInfoSys.com June 4, 2009 Confidential & Proprietary ImpactInfoSys.com

Thank you for your time. For More Information: www.impactinfosys.com [email_address] 302.573.6864 x105 June 4, 2009 Confidential & Proprietary ImpactInfoSys.com June 4, 2009 Confidential & Proprietary ImpactInfoSys.com

Compliance In A Box Documentum Deployment Solution

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