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Best Practices for Vault QualityDocs Implementations October 21, 2014

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Page 1: Best Practices for Vault QualityDocs Implementations€¦ · Best Practices for Vault QualityDocs Implementations October 21, 2014. Dana Sisti Practice Manager, Vault R&D Professional

Best Practices for Vault QualityDocs ImplementationsOctober 21, 2014

Page 2: Best Practices for Vault QualityDocs Implementations€¦ · Best Practices for Vault QualityDocs Implementations October 21, 2014. Dana Sisti Practice Manager, Vault R&D Professional

Dana SistiPractice Manager, Vault R&D Professional Services

Page 3: Best Practices for Vault QualityDocs Implementations€¦ · Best Practices for Vault QualityDocs Implementations October 21, 2014. Dana Sisti Practice Manager, Vault R&D Professional

Heather McHughSenior Consultant, Vault R&D Professional Services

Page 4: Best Practices for Vault QualityDocs Implementations€¦ · Best Practices for Vault QualityDocs Implementations October 21, 2014. Dana Sisti Practice Manager, Vault R&D Professional

®2014 Veeva Systems – Company Confidential veeva.com | 4

Session Goals

Illustrate primary phases in a Vault QualityDocs implementation

Planning

Design and Configuration

Validation

Deployment

Identify critical data needed for each phase

Explore common pitfalls

Page 5: Best Practices for Vault QualityDocs Implementations€¦ · Best Practices for Vault QualityDocs Implementations October 21, 2014. Dana Sisti Practice Manager, Vault R&D Professional

Planning

Page 6: Best Practices for Vault QualityDocs Implementations€¦ · Best Practices for Vault QualityDocs Implementations October 21, 2014. Dana Sisti Practice Manager, Vault R&D Professional

®2014 Veeva Systems – Company Confidential veeva.com | 6

Where do you want to go with Vault QualityDocs?

Page 7: Best Practices for Vault QualityDocs Implementations€¦ · Best Practices for Vault QualityDocs Implementations October 21, 2014. Dana Sisti Practice Manager, Vault R&D Professional

®2014 Veeva Systems – Company Confidential veeva.com | 9

Why Vault?Set Project Goals, Long-Term and Short-Term

Are you:

Coming from an inefficient, paper / manual process?

Do you:

Need to harmonize or standardize your processes, locally or globally?

Have you:

Been issued a finding and been cited for lack of compliance?

Does your:

Existing system not meet your users’ requirements?

Page 8: Best Practices for Vault QualityDocs Implementations€¦ · Best Practices for Vault QualityDocs Implementations October 21, 2014. Dana Sisti Practice Manager, Vault R&D Professional

®2014 Veeva Systems – Company Confidential veeva.com | 10

Planning Keys to Success

Validation Plan (Who, What, When)

Migration Plan (Who, What, When)

Project Plan

Have a Plan.

Project Sponsor

Page 9: Best Practices for Vault QualityDocs Implementations€¦ · Best Practices for Vault QualityDocs Implementations October 21, 2014. Dana Sisti Practice Manager, Vault R&D Professional

Design and Configuration

Page 10: Best Practices for Vault QualityDocs Implementations€¦ · Best Practices for Vault QualityDocs Implementations October 21, 2014. Dana Sisti Practice Manager, Vault R&D Professional

®2014 Veeva Systems – Company Confidential veeva.com | 12

Requirements Gathering & Design Workshops

Business representation is critical

Let’s meet face-to-face

Know your documents

Embrace the iteration

Configuration

Requirements

Page 11: Best Practices for Vault QualityDocs Implementations€¦ · Best Practices for Vault QualityDocs Implementations October 21, 2014. Dana Sisti Practice Manager, Vault R&D Professional

®2014 Veeva Systems – Company Confidential veeva.com | 13

Vault QualityDocs Key FeaturesFully understand product capabilities

Intuitive Design

Periodic Review

Controlled Copies

Configurable Workflows

Reports and Dashboards

Signature Manifestations

Integrated Change Control

Read & Understood

Watermarking and Overlays

Page 12: Best Practices for Vault QualityDocs Implementations€¦ · Best Practices for Vault QualityDocs Implementations October 21, 2014. Dana Sisti Practice Manager, Vault R&D Professional

®2014 Veeva Systems – Company Confidential veeva.com | 14

Building Out the Workflow and Lifecycle

Stay with the Basics

90% of typical scenarios addressed

by OOTB lifecycles and workflows

Don’t overcomplicate with

“special rules”

Stay Flexible

Expect processes for different

content types to work differently

Define the object model in the way

that makes sense to you

Page 13: Best Practices for Vault QualityDocs Implementations€¦ · Best Practices for Vault QualityDocs Implementations October 21, 2014. Dana Sisti Practice Manager, Vault R&D Professional

®2014 Veeva Systems – Company Confidential veeva.com | 15

Design Verification

Design Based

on Gathered

Requirements

Dry Run with

Process

Exercises

Incorporate

Feedback from

Testers

Design VerificationAccelerate user interaction and feedback

Build Design in

Vault through

Configuration

Page 14: Best Practices for Vault QualityDocs Implementations€¦ · Best Practices for Vault QualityDocs Implementations October 21, 2014. Dana Sisti Practice Manager, Vault R&D Professional

®2014 Veeva Systems – Company Confidential veeva.com | 17

Migration Considerations

Scope of Migrated

Content

Audit Trails

Document Numbering Migration

Phased or Complete

Migration

Configuration

Modifications

Template Adjustments

Page 15: Best Practices for Vault QualityDocs Implementations€¦ · Best Practices for Vault QualityDocs Implementations October 21, 2014. Dana Sisti Practice Manager, Vault R&D Professional

User Acceptance Testing and Validation

Page 16: Best Practices for Vault QualityDocs Implementations€¦ · Best Practices for Vault QualityDocs Implementations October 21, 2014. Dana Sisti Practice Manager, Vault R&D Professional

®2014 Veeva Systems – Company Confidential veeva.com | 20

Validation

Veeva provides a comprehensive package of validation

accelerators that will substantially reduce your validation effort

Page 17: Best Practices for Vault QualityDocs Implementations€¦ · Best Practices for Vault QualityDocs Implementations October 21, 2014. Dana Sisti Practice Manager, Vault R&D Professional

Reducing the Burden of Computer System ValidationBryan Ennis

Wednesday 11-11:45am

Page 18: Best Practices for Vault QualityDocs Implementations€¦ · Best Practices for Vault QualityDocs Implementations October 21, 2014. Dana Sisti Practice Manager, Vault R&D Professional

Deployment

Page 19: Best Practices for Vault QualityDocs Implementations€¦ · Best Practices for Vault QualityDocs Implementations October 21, 2014. Dana Sisti Practice Manager, Vault R&D Professional

®2014 Veeva Systems – Company Confidential veeva.com | 23

Ensuring a Successful Deployment

Gain internal awareness

Communication plan (emails, lunch & learns, website, etc.)

Identify and leverage super users

Plan for long-term training

After initial training, establish self-help training and onboarding process

Establish Internal help desk and support processes

Institute a Governance Model

Page 20: Best Practices for Vault QualityDocs Implementations€¦ · Best Practices for Vault QualityDocs Implementations October 21, 2014. Dana Sisti Practice Manager, Vault R&D Professional

®2014 Veeva Systems – Company Confidential veeva.com | 24

Summary

PlanningDesign and

ConfigurationValidation Deployment

Understand your

starting point -

“Why Vault?”

Set goals – and

regularly refer to

them

Establish a

validation and

migration strategy

Get the right

people in the

room

Know your

documents and

existing records

Plan for

migration

Execute

UAT/Validation

Plan

Leverage Veeva

validation

deliverables

where

appropriate

Veeva can help!

Hype Veeva

internally

Define training

plan

Institute support

processes and

governance model

Page 21: Best Practices for Vault QualityDocs Implementations€¦ · Best Practices for Vault QualityDocs Implementations October 21, 2014. Dana Sisti Practice Manager, Vault R&D Professional

Thank YouDana Sisti

[email protected]

Heather McHugh

[email protected]

Page 22: Best Practices for Vault QualityDocs Implementations€¦ · Best Practices for Vault QualityDocs Implementations October 21, 2014. Dana Sisti Practice Manager, Vault R&D Professional

®2014 Veeva Systems – Company Confidential veeva.com | 26

Complete the session survey with the Veeva app

Thank you

Search “Veeva” in app store

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