sampleminded® Support Overview

Last Updated: 1/22/2013

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Objective and Agenda

Our objective today is to:• Provide an overview of the sampleminded™ support & service desk process

Agenda• Service Overview

• Collaboration

• FAQ Sheet (Who, Where, What, When, Why)

• Process Overview

• Demonstration/ Training of sampleminded™ Service Desk

Service Overview

• Maintain system Infrastructure

• System administration & monitoring

• Application support for bug fixes and regression testing

• Maintain application quality and data integrity

• Data retention and data custodian

• Provide 3rd-tier application to named support contact

• Disaster recovery planning and support

• Generic help documentation

• Regulatory compliance readiness (HIPPA, FISMA, 21 CFR Part 11)

• Facilitate advisory and user groups

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• Data in Motion provides sampleminded™ as a service. The following roles and responsibilities are included as part of the service.

Typical Customer Responsibilities

• Update study configuration

• New study configuration

• Data edits

• Data owner & data curators

• New study preparation and testing

• End user management (create, maintain, terminate users, i.e. user life cycle)

• End user support & training

• Data validation

• Application validation for specific customer intended use

• Application system testing

• Commitment to upgrade to most recent version of sampleminded®

• Maintain customer-specific documents to trouble-shoot application issues -- study specifications, data extract specifications, demo data files (kits, subjects, samples, derivatives)

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Collaboration Overview

Our unique collaboration option allows customers to sculpt the software to their exact needs.

What you do:

•Participate in the definition of feature requests•Give feedback on design storyboards•Help test the new feature

What you get:

•Discounted Collaborator pricing•Early releases•A listing as a Collaborator on our website•Software that meets your needs exactly

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Support and Collaboration Overview

• What: A bug, defect, feature request, data edit request, need or issue with CliniTraq is defined as a service request in the sampleminded™ Service Desk (CSD).

• Who: A named support contact can enter a service request in CSD.

• Where: https://jira.data-inmotion.com

• When: The online access to the support desk will be available 7 x 24. Service requests will be reviewed and dispositioned for work according to the service level agreement (SLA). Critical defects and outages get the highest priority. Customers are encouraged to enter service requests ASAP.

• Why: Service requests will facilitate the management of application support, resourcing, issue tracking, SLA metrics, documentation and quality requirements.

Support Workflows – Mange Service Desk

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Support Workflows – Mange Bug Report

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Support Workflows – Manage Data Edit Request

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Support Workflows – Other type of Service Request

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• sampleminded™ offers change management best practices for application configuration changes.

• Customer can implement new studies or study updates using the study builder tool at its convenience

• New studies / study updates can be implemented during any weekly maintenance window

• Customer submits a change control ticket and attends a change control meeting to push new study or study update into PRODUCTION system

• Best practice supports regulatory requirements and promotes system stability

Change Management Offering (Optional)

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Planning Phase

• Prepare study configuration specification including tube table, specimen table, Schedule of events, Lab Manual, etc

• Complete DIM service request

Config Phase

• Configure study in sampleminded™ QA environment

ValidationPhase

• Test configuration - Customer test cycle• Integration testing - Regression test other studies,

all importers/exporters, and data extract• End user setup and security definition

Training • Training &Rollout preparation

Change Control

• Review customer’s QA evidence / risk analysis• Tag configuration release in SVN• Perform releaseCustomer taskCustomer task

DIM TaskDIM TaskKey

Study BuilderStudy

Builder

Sample process overview for configuration changes