9 regulatory compliance and validation for li

Selling AX Validation Services:What You Need To Know

Valarie King-Bailey, M.B.A.Chief Executive Officer

OnShore Technology Group

Today’s TopicsLife Sciences Industry Challenges

What Is Validation?

How Do You Sell It?

How Much Does It Cost?

What Is The Validation Toolkit?

Validation Automation – What You Need To Know

What Every Partner Should Know

Software Validation In The Global Life Sciences Industry

Life Science Industry Challenges

Pharmaceutical

Biotechnology

Medical Devices

$ 62BN of sales will be lost to Generics in the US by 2011

In 2011 the Pharma industry will face negative growth

Costs of taking a drug to Market in US exceeds $1.4B

Biosimilar legislation in US puts billions of revenue at risk

Most hospitals have WiFi, but they struggle with Device Mgmt

As much as 80% of revenue comes from new products (< 2

yr old)

Only 1 in 20,000 compounds make it to market

New regulations appear regularly from both states and

feds

• Disparate Systems• Legacy Systems• Huge Amounts of

Data/Records• High Cost of Downtime• Lack of Automation

Between Machines / Systems

• Internal “Production Focus” Metrics

• Many Manual Touch Points

• We Validate All GMP Functionality In AX

Compliance in the Manufacturing EnvironmentHas a Unique Set of Challenges

FDA Validation Toolkit

Partial List of AX Clients

SONEXUS HEALTH

What is Independent

Validation &Verification

(IV&V)?

FDA Definition Of Validation

“Validation is a process of demonstrating, through

documented evidence, that <software applications> will

consistently produce the results that meets predetermined specifications and quality

attributes.”

Why Independence?

Developers CANNOT

Check Their Own Work

Ensures Objectivity

Ensures Quality

Key Terminology 1. IQ – Installation

Qualification

2. OQ – Operational Qualification

3. PQ – Performance Qualification

4. Part 11 – 21 CFR Part 11 Electronic Records; Electronic Signature Final Rule

5. SOP – Standard Operating Procedure

6. GMP – Good Manufacturing Practices

7. GAMP 5 – Best Practice Methodology for Validation

8. Predicate Rule – Any law in the US Code of Federal Regulations (CFR)

9. QA – Quality Assurance

10. Change Control – Required process for changes to validated systems

FDA Validation Toolkit

Our Validation Methodology

GAMP 5® is an international standard designed to harmonize validation requirement across the globe. It was written by a life sciences industry consortium.

PARALLELS SURESTEP® METHODOLOGY

Quality Attributes

Safety

Efficacy

Potency

Purity

Stability

Consistency

GAMP 5 System Lifecycle

Typical Validation Project Implementation Process

ERP Engagement Project Plan

AX Deployment Options

Hosted (Data Center) On-Premise Virtual

EACH OPTION HAS UNIQUE IMPACT ON VALIDATION You need to understand the impact

on software validation of each option

Requirements For AX Data CentersMust Be SOC 1/SOC 2 Compliant (Replaces SAS 70Data Center Personnel Must Be TrainedChange Control Is REQUIREDMaintaining The Validated State

What Is The Risk of NOT Validating AX?

“…You have failed to validate computer software for its intended use according to an established protocol, when computers or automated data processing systems are used as part of the production or the quality system, as required by 21 CFR 820.70(i)…”

FDA 483’s (Cont.)

You have failed to document maintenance activities, including the date and individuals performing those activities, as required by 21 CFR 820.70(g)(1).

FDA 483’s (Cont.)

“…Failure to validate software used as part of production and quality system for its intended use according to an established protocol, and failure to document the results of the software validation, as required by 21 C.F.R. § 820.70(i)… Specifically, your firm has not maintained documentation of the validation of the computer software…”

The Business Case For Validation

Advantages Of Software Validation:• Ensures Repeatability & Consistency• Ensures Software Quality & Production

Readiness• Ensures Software Performs According To Its

INTENDED USE• Decreases The Risk Of The Manufacturing

Problems• Decreases The Expenses Caused By The

Failures In Production• Decreases The Risks Non-Compliance With

cGMP Guidelines

How Do You Sell Validation Services?

Unique Characteristics of Selling in Life Sciences

Long Sales CyclesGMP Domain ExperienceValidation PerceptionsEverything Must Be Documented

Extensive Pre-sales EducationMust understand regulationsDeployment Environments MatterValidation Parallels Implementation

Sales Cycle ActivitiesThink Validation FIRST!

Ask About Outsourcing Versus In-House Validation

Ask About Deployment Environment (Hosted/On-Premise)

Complete Validation Questionnaire With Prospect

Do NOT Quote Fixed Price (T&M Only)

Bring Validation Team In As Early As Possible

FDA Validation Toolkit

The Ideal ProspectWho Should Be In The Room?

Q: Within your organization, what functional group is ultimately responsible for selecting and prioritizing ERP software investments?

Senior Executive Management

Corporate IT

Business Operations

Finance/Accounting

Plant or Manufacturing IT

Marketing/Sales

HR/Personnel

Plant Manager

0% 5% 10% 15% 20% 25% 30% 35% 40% 45%

41%

27%

18%

7%

6%

1%

0%

0%

AMR Research ©2012

Sales Cycle May be Extended if:You do not have a clear

understanding of client requirements

Client is uncomfortable with your knowledge of validation

You fail to give them a comfort level with the services they will

receive

You are caught in a price bidding war

You cannot answer their questions during the sales

process

Prospecting Questions To Ask

1. What is your experience with software validation?

2. Will the system be deployed in a data center or on-premise?

3. What GMP processes are affected by AX

4. What customizations will you require?

5. Do you have a written set of requirements?

6. Will you be migrating any information as part of this project?

7. Will you be using 21 CFR Part 11 Electronic Signatures?

10 Things You Need To Know When Selling in a Life Sciences Environment1. Software

Validation

2. Regulations

3. Importance of Change Control

4. 21 CFR Part 11

5. Industry Differences

6. Security Challenges

7. Data Center Validation

8. Migration Considerations

9. Everything Has To Be Documented

10. Impact of Customizations

How Much Does Validation Cost?

Software

Failures

Defects

Minor Cosmetic Defects

Critical/Major Software Defects

S/W Failures by Other Events

Worldwide cost of IT failure: $6.2 trillion

Minimize Cost

Of Validation & Verification

Rapid Deploymen

t Of Dynamics

AX/NAV

Minimize Risk

Across Project

MaintainingA Validated State Over Time

On The Minds Of Your Prospects…

Ensure ComplianceWith cGMP Regulations & 21 CFR Part 11

What is the ideal customer profile for validation?

Significant ERP/Compliance Pain

Knowledgable About Regulations

Customer With Approved Budget

SMB Pharma/Med Device/Biotech/CRO

IT Director/VP Who Understands Validation

When Do I Introduce software validation?

AT THE BEGINNING

OF THE SALES CYCLE!

Ask Prospect does the system require

validation upfront

Mention the Validation

Toolkit as a validation starting

point

Ask to speak to QA

regarding their

validation process

The Importance of PriceValidation Is Often Thought Of As Expensive & Time-Consuming• Clients Do Not Want To

Reproduce Validation Document Deliverables

• Expect Vendor To Have Deep Knowledge

• Sometimes Views Validation As ‘Necessary Evil’

Emphasize Anticipated Cost Savings Using The Toolkit and Automation Tools

Low Range• $100 - $200k• OTB

Installation

Medium Range• $200 - $400k• Some

Customizations

High Range• $400 – 600k+• Significant

Customizations • Integrated 3rd Party

Applications

TYPICAL VALIDATION PROJECT COSTS

Understand The Impact of Software Customizations

More Customization = More Validation

Less Customization = Less Validation

Why Life Sciences Deals Are Lost?

Don’t Understand Validation Requirements

Dont Understand The Industry Sector Challenges

Cant Speak the language of life sciences companies

Don’t Involve The Validation Team Early Enough

Don’t Adopt Validation Processes Into The Overall Implementation Project

Validation is an AFTER THOUGHT

7 Habits of Highly Effective Sales Reps

Sharpen the Saw: Commit To Life Long Learning &

Improvement

Be Flexible: One Size Does Not Fit

AllEmphasize ValueEstablish

Credibility EarlyLearn The

Language of Validation

Get The Right People In The

RoomListen!

1 2 3 4 5 6 7

What Is The Validation Toolkit?

21St Century Validation

Validation Toolkit Overview

Templates

IQ/OQ/PQ Test Scripts

Training

Validation

SharePoint Portal

Delivered onSold Through

Validation Portal• Based on MS

SharePoint Portal

• Track and Manage Validation Documents

• Efficient Collaboration

• Essential For Good Document Control

• Delivered With Full Service Engagement

AUTOMATED VALIDATION

TESTING IS HERE!

Capture OQ Tests Real Time

Execute Scripts Electronically

Automated Validation TestingCustomizable Output in Microsoft Word Format

Automatically Generate Pass/Fail

Reports

Easy To Edit/Export IQ/OQ Scripts

Insert New Steps To Your OQ Script With

Ease

Export Scripts To PDF/Word or Other Format

Run Captured OQs Live

• Allows Real Time OQ Test Script Execution In The Actual Software Environment

• Reports Failures During Execution

• Excellent For Re-validation Exercises

• Saves 60% of Testing Time

PROCEDURE CAPTURE IS OPTIONAL AND IS AVAILABLE FROM ONSHORE TECHNOLOGY GROUP

Validation Service Options

Validation Services OfferingsValidation Complete℠

• Full Service Validation

• (3) Person Team

• Validation Project Management

• Preparation of all Deliverables

• Automated Validation Testing

• SOP Development (optional)

Validation Coach℠

• Only For Customers w/Knowledegable Internal ValidationTeam

• Validation Staff Augmentation & Coaching

• Assistance w/Validation Deliverables

• Sold On Monthly Basis

• SOP Development (optional)

What EVERY Partner Should Know For Success

Common Problems Working With Partners

No Understanding Of The Validation Process

No Understanding Of Regulatory Requirements/Impact

Over-Customization

No Process Control During AX Configuration/ Development

Failure To Establish Change Control Lack of Training

Recommendations For Success

To Ensure Success…Think Validation FIRST!

Understand Applicable Regulations

Understand Deployment Options (hosted, on-premise)

Don’t Over-customize

Train! Train! Train!

Sell Toolkit and Automation Testing Tools

Understand Validation Service Options

Valarie King-Bailey, M.B.A.CEOOnShore Technology Group, Inc.505 N. Lake Shore DriveChicago, Illinois 60611312.375.4300 www.onshoretech.com

For more information about software validation, please feel free to call

THANK YOU!