Leveraging Cloud toEnable Agility in 

Regulated Industries

31 March, 2015Amy Shutkin, Senior Project Manager, NateraBob Kenney, Customer Success Manager, Veeva Systems

• Fast growing genetic testing company that develops and commercializes non‐invasive methods for analyzing DNA

• Company Mission: Help families diagnose and manage genetic disease

• Building innovative cloud‐based products for global life sciences industry

• Over 200 customers in 80 countries

• Company Mission: Customer Success, Employee Success, Speed

Companies

• Disruptive Innovation• Regulation and Innovation• Agile Methodology• Role of EDMS and Selection Process• Document Change Control• Successful Migration• Conclusions

Discussion Overview

Disruptive InnovationProd

uct P

erform

ance

Time

Three Horizons of GrowthMcKinsey & Company

Profita

bility

0‐2 years

H1: defend & protect the core business

H2: penetrate adjacent markets

H3:  create or develop new markets

3‐5 yearsTime

>5 years

Disruptive Innovation at Natera

Panorama™ Non‐Invasive Prenatal Testing

Innovation vs. Regulation

• Regulatory Requirements– FDA 21 CFR Part 11

• Esignatures etc.

– ISO‐13485– CAP accreditation– CLIA certification– New York State DOH– IEC‐62304

Regulatory Compliance

Confidential and Privileged

Product LaunchProduct Launch

9

Design Control Drives New Products to Market

Concept Feasibility & Planning Development Validation Rollout & 

Launch SustainingG1 G2 G3 G4 G5

Idea screen Build business case

Try

Fail

Learn

Development Testing & Validation

FDA mandates   stage‐gate process but no guidance on how that is achieved

Feasibility & Planning Gate:  Design Review

Feasibility & Planning Gate:  Design Review

Management Go/No Go decision

Management Go/No Go decision

Development Gate:  Design 

Review

Development Gate:  Design 

Review

Validation Gate:  Design 

Review

Validation Gate:  Design 

Review

Product Development Characteristics 

• Put stake in the ground

• Cross‐functional iterations

• Challenge the results

• Rapidly change direction

BENEFITS OF AGILE PROCESSES

Fail Fast and Learn

Allows for Change

Early Risk Mitigation

Respond Faster

Enables Work in Parallel

Predictable Results

Agile/Scrum Methodology

Confidential11

How do we sustain our agility in regulatory environments?

Case Studies

Confidential12

Flexibility is the critical success 

factor!

“…too much structure can inhibit creativity.”

Adhering to stage gate process while building in flexibility

Design History File Documents 

Quality Management System (QMS) Deliverable Feasibility and

Planning Development Validation Launch Responsible Design History

File (DHF) D U U U,C QA

Requirements Document D U U C Product Mgmt

Specifications document D U U C R&D (Mol Bio,

Stats, Biofx, EngRegulatory Plan D U U C QA

Risk Mgmt Plan / Assessment D U U C

Product Development

Team

Design Plan and Key Milestones D U U C

Team Lead withMol Bio, Stats,

Biofx, Eng Service and Support Plan D U C Support

Traceability Matrix D U C

Product Development

Team Design

Verification Protocol

C C C R&D w/ Team Lead, Biofx, Eng

Manufacturing Plan D U C Manufacturing

Deliverable Feasibility and Planning Development Validation Launch Responsible

Sales Forecast D C Sales Marketing Plan D C Marketing

Post Market Surveillance D C

Customer Support, Produc

Transfer Regulatory

Notifications and Approvals

D C Regulatory

Manufacturing Procedures D C Manufacturing

Design Validation Protocol

D,C C Project Leader wR&D, Biofx, Eng

Design Validation

Report C C Project Leader w

R&D, Biofx, Eng

Labeling Plan D C Manufacturing Stability Studies

Protocol D,C C

Development

Stability Studies Report

D,C C Development

Design Validation

Report D,C C

Project Leader wR&D, Biofx, Eng

Software Verification and

Validation Report

D,C C Project Leader

Supplier Evaluation

D,C C Manufacturing

Launch Plan D C Product

Development Team

Manufacturing and Supplier Agreement

C Manufacturing,

Legal

D = DraftU = UpdateC = Complete

Regulatory and Quality Assurance Requirements Comments

1. Ease of UseIT requirements, document status and reporting capabilities, dashboards

2. Web‐based Cloud‐based, device agnostic

3. Search FunctionalitySearch by document metadata and full text, saved searches

4. Change Order/ControlIterative version/revision control, workflow management

5. Training AutomationLinked to new &/or changed documents, automated calendar retraining scheduling

6. Simultaneous Editing Document review/revision management

7. Security / Access Privileges Legal and IP protections

8. Audit Trails Laboratory focus / CLIA & ISO compliant

9. Integration with Gmail, Okta Automated assignments, reminders

10. FDA 21 CFR Part 11 & HIPPA Compliant Electronic signature support

EDMS Requirements (Not Ranked)Regulatory Compliance is Fundamental

EDMS Vendor Heat MapDeveloped by Natera

Requirements A B C D E Veeva Vault QualityDocs

1 Ease of Use 4 4 3 3 4 5

2 Web‐based 3 4 3 5 5 5

3 Search Functionality 4 3 1 3 3 5

4 Change Order/Control 2.5 2.5 1 1 2.5 4

5 Training Automation 5 3 2 1 5 5

6 Simultaneous Editing 2.5 2 1 4 2 4

7 Security / Access Privileges 3 3 1 2 4 5

8 Audit Trails 5 4 1 1 5 5

9 Integration with Gmail, Okta 3 2 2 4 4 4

10 FDA 21 CFR Part 11 & HIPPA Compliant

5 4 1 2 4 5

Example of Savings Analysis

Average Hourly Creator/Approver Wage $50 $50 n/a

TOTAL COST TO MANAGE A DOCUMENT $4,700 $975

Number of New Documents Per Year 100 100

Average Percent Document Revisions Per Year 25% 25%

Total Documents Per Year 125 125

ANNUAL COST TO MANAGE ALL DOCUMENTS $587,500 $121,875

Manually(in hours)

Automation via Vault

(in hours)

Percent Savings

Note: Numbers are representative and for illustration purposes only. They do not reflect company’s actuals.

Document Change OrderWord Template Form

DocumentDocumentDocument

Document Change OrderMultiple Affected Documents

Document Change Order

Document Document Document

New Revise Withdraw

SOP‐00108SOP‐00108SOP‐00108SOP‐00108SOP‐00108SOP‐00108

Document Change OrderApproval Process & Version‐Specific Relationships

DCO‐00014

SOP‐00108

v0.1

v1.1

DCO‐00014

SOP‐00108

v1.0

v2.0

SOP‐00108

v2.0

Draft

Draft

DCO‐00014

v0.3

In Approval

SOP‐00108SOP‐00108

SOP‐00108

v1.4

On DCO

Approved

Approved

Doc ControlApproval & Release

Effective

Optional Iterative Review

Release Doc

Document Change OrderBenefits Compared to Document Change Request

UpdateDoc

Redlined DocCopy

Create DCO

Create DCR

UpdateDocs

Change Request Process

Change Order Process

Release Docs

Release Doc

Approve DCR

Approve DCO

Release Doc

Approve Docs

Approve Doc

DEMONSTRATIONDocument Change Control

Successful Migration

Buy‐in From‐ Executive Team‐ Cross‐Functional 

User Group 

Buy‐in From‐ Executive Team‐ Cross‐Functional 

User Group 

Mindful Shift in CultureVend

or Evaluation

Rollout Initial 

Users

2nd Rollout

3rd Rollout

nth Rollout

Make it Easy

Phased Rollout‐ Leveraged Vault’s R&U ‐ New group of users per week

Accessible Self‐Help Training

Clinical Lab Trainers

QA Executives

….

Migration ETL Best Practices

IdentifyMigration approachDocument inventory

ExtractExtract from source(s)

Data MappingMap source / targetReview & update data

TestDry run load processUpdate data as needed

LoadExecute loadVerify migration

• Define data to be migrated: core subset, or full data?• Data owners extract and transform• Use a product for extract, transform, and load steps where possible• Create PDF of source audit trail and associate to migrated record• Use reports to verify / document results• Test business processes using migrated records

Migration and Implementation

System Design

System Configuration

Validation Testing

Implementation Migration

Production Deployment and Data Migration

Identify Source Data

Perform Data Mapping

Perform Data Augmentation

Migration Dry Run

• Benefits of Agile for Innovation• Build Agility into the Stage Gate Process• The Right Application Enables Agility in a Highly Regulated Environment– E.g. supports the 34 requirements for electronic signatures

– Flexible and Configurable Document Change Control Options

Conclusion

QUESTIONS?

• Migration and new system• 1. What were you using before?• Answer: We were on paper and tracking documents manually

• 2. What was the biggest challenge moving to the new system?

• 3. What documents are you managing in the new system?

• 4. Were there any  other benefits than agility?• Answer: We can mitigate risks ‐ we have visibility into the process e.g. who has not 

completed their R&U tasks, reduced our compliance risks with detailed audit trails and electronic signatures that are 21 CFR Part 11 compliant

• Evaluation• 5. How long did it take to evaluate all the vendors and can you provide some more 

info on the evaluation process? Was there an RFI (request for information) you used, demos, or POC?