Steps we followed

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Case Study – Upgrading to the Next Generation User Interface for Documentum • Description of the Application

• Needs of the Customer

• Requirements for the project:

• Application Requirements

• Other Requirements

• Approach for Selection of Next Generation User Interface

• Agnostic Assessment

• Requirements Based Assessment

• Final Results

Description of the Environment

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The system is used world wide for management of regulated and controlled content in a Research and Development division of a Life Science company.

• The system was built to handle a large number of use cases including:

• GxP management of controlled Documents – SOPs, Procedures, Policies, Forms, etc.

• Manage regulatory documents such as Clinical and Pre-Clinical documentation

• Regulatory Submissions – Publishing and management of submissions such Marketing Authorization

• Product labeling management (Structured Product Labeling - US, EU Labeling)

• Vendor Management – 3rd party vendor access

• Translation Creation and Management

• Template Management

• The system was implemented through customizations to XmLabeling deployed on WebTop

Next Generation Needs of the Business Customer

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• The ability to customize the user interface based on the user profile

• Filtering based on document type and metadata

• Ability to view more information about the documents, and to control what information they see via Widgets

• Find things quickly and easily, i.e. efficient searching

• Quick access to documents to high use rate Content

• Dashboard views based on use case

• SharePoint integration for collaboration on unregulated content

• Mobile functionality – Including workflow participation from email, and content exposure all via the WAN

• Integration with other Enterprise systems

Next Generation Needs of the Technology Customer

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• Concerned about support for 3rd party product due to its dependency on WebTop

• Need to upgrade content server to Documentum 7

• Company has a shared Documentum content server environment – several different repositories use the same Documentum infrastructure

• Need for content repository to be on a supported configuration

• Current system has a number of performance/stability issues that are difficult to resolve issues due to the number of application levels.

• Desire to reduce costs by moving to configurations vs. customizations

Key Application Requirements For the Next Generation UI

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• Workflow – 21 CFR Part 11 compliant electronic signatures, preconfigured templates/adhoc review workflows, reporting, integration with life cycles, commenting during review

• Searching – Advanced search based on a number of attributes, content based searching, saved searches, filtered views based on document type and metadata

• Integration with other systems – Read only access to documents in other systems, document creation from other systems utilizing configured system functionality to apply security, folder location, etc.

• Specialized vendor management – Management of 3rd party vendors and their security rights for accessing and modifying document information.

Application Requirements

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• Virtual document functionality, for example:

• Create a new virtual document structure

• Copying a structure

• Creating a virtual document snapshot

• Create structure from template

• Translation management – multiple language translations of approved master document version

• XML Content - Labeling documents and eCTD (XML applications for handling of xslt, xml and images, virtual document relationships for linking components in to a structure)

Next Generation Use Case Requirements

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• Ease of configuration management

• Application performance – very important with worldwide deployment and a large number of documents

• Simplify future upgrades by reducing customizations and moving to a supported platform

• Separation of content server upgrade from application upgrade –flexibility in upgrade process due to dependency on other systems sharing the architecture

UI Solution Selection Process

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• Performed a Use Case agnostic assessment of solutions head to head as industry applicable requirements.

• Performed assessments with User Communities to gather next generation user experience needs.

• Created a set of technology level Needs focused against the Corporate and IT Department strategic plans.

• Review the new composite sets of user and technology requirements against the current and expected regulatory environment.

• Created a Migration plan for the UI solutions for both the business and the content.

Use Case Agnostic Assessment

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• Identify a criteria for rating the application in the following categories:

• System functionality

• Business change impact

• Technical architecture

• Costs

• Vendor viability

• Support and maintenance

• Assign a rating to each criteria based on:

• Product demonstration

• Working with the product

• Apply a weighting, based on the customer’s prioritization, to the average score of each category and calculate a score for each application.

Use Case Agnostic Assessment Results

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Results of Use Case Agnostic Assessment

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• The use case agnostic assessment was based on many areas of the applications. Both applications had strengths in different areas which made the final score fairly close.

• Ratings were subjective based on a scale of 1 to 10 based on configurability, ease of use, out of the box features, etc.

• Although the assessment was not able to clearly show which application was the best choice for this customer, it did help identify strengths and weaknesses in the applications that created much larger gaps when the customers requirements were considered.

Client Specific Requirements Assessment

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• Review the Business Requirements and Design Specification of the current system to identify application requirements

• Categorize the Requirements

• Establish a rating scale for each category based on customer feedback

• Assign a rating for each requirement based on the candidate application - OTB, Configuration, Customization, 3rd Party Tool, etc.

• Summarize Results

Assessment Based on Application Requirements

Assessment Based on Application Requirements

Results of Client Requirements Assessment

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• There were a number of requirements identified that would not be met until a future version of one of the applications is released.

• Although both applications had their strengths, requirements for Virtual Documents, searching capabilities and the ability to customize the interface gave one of the applications a clear advantage over the other.

• Results of the assessment along with roadmap information on when certain features would be available were provided to the customer for their consideration.

Summary

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• The customer was provided with a non-biased 3rd party assessment of the applications for their consideration along with their own assessment of the applications through sales demonstrations, discussions with the vendors and working with in house demonstration environments.

• Interaction with both vendors was very positive. The vendors were very responsive with demonstrations, product strategies, roadmaps and discussions on implementing requirements. We were able to identify gaps to them, and discuss options on how their products might satisfy the requirements.

Reaching the Next Generation User Experience

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• Based on our recommendations and the customers personal assessment, the customer is in the process of selecting the application.

• Provide a clearly sequenced migration plan to realize the user requirements while maintaining compliance. The plan will include the following components:

• Content migration plan

• Configuration migration plan

• Infrastructure upgrade plan

Financial Stability

- Revenue of $144 M USD

- Rapid Growth: 60% CAGR (5 years revenue)

Global Presence

- 8 countries & 12 offices

- 1500+ employees

-500+ customers

Process Maturity

- CMMi Level 5

- PCMM Level 3

- ISO 27001

Recognition

- Leader in R&D Outsourcing by IDC MarketScape

- Deloitte Tech Fast 50

- Innovation top 50 (NASSCOM)

PRIMARY INDUSTRY FOCUS

KEY SOLUTIONS & SERVICES

Regulatory & Compliance

Regulatory Document Management & Submissions

Pharmacovigilance & Drug Safety

Functional Service Provider

Clinical Data Transformation

Enterprise Content & Collaboration Services

Business Intelligence & Data Warehousing

Application Management & Testing

Business Process Management

Life Sciences

A Global Business Technology Solutions Company

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