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Selling AX Validation Services:What You Need To Know
Valarie King-Bailey, M.B.A.Chief Executive Officer
OnShore Technology Group
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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
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Software Validation In The Global Life Sciences Industry
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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
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• 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
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FDA Validation Toolkit
Partial List of AX Clients
SONEXUS HEALTH
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What is Independent
Validation &Verification
(IV&V)?
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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.”
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Why Independence?
Developers CANNOT
Check Their Own Work
Ensures Objectivity
Ensures Quality
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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
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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
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Quality Attributes
Safety
Efficacy
Potency
Purity
Stability
Consistency
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GAMP 5 System Lifecycle
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Typical Validation Project Implementation Process
ERP Engagement Project Plan
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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
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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
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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)…”
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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).
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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…”
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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
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How Do You Sell Validation Services?
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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
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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
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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
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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
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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?
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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
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How Much Does Validation Cost?
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Software
Failures
Defects
Minor Cosmetic Defects
Critical/Major Software Defects
S/W Failures by Other Events
Worldwide cost of IT failure: $6.2 trillion
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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
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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
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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
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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
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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
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Understand The Impact of Software Customizations
More Customization = More Validation
Less Customization = Less Validation
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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
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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
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What Is The Validation Toolkit?
21St Century Validation
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Validation Toolkit Overview
Templates
IQ/OQ/PQ Test Scripts
Training
Validation
SharePoint Portal
Delivered onSold Through
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Validation Portal• Based on MS
SharePoint Portal
• Track and Manage Validation Documents
• Efficient Collaboration
• Essential For Good Document Control
• Delivered With Full Service Engagement
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AUTOMATED VALIDATION
TESTING IS HERE!
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Capture OQ Tests Real Time
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Execute Scripts Electronically
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Automated Validation TestingCustomizable Output in Microsoft Word Format
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Automatically Generate Pass/Fail
Reports
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Easy To Edit/Export IQ/OQ Scripts
Insert New Steps To Your OQ Script With
Ease
Export Scripts To PDF/Word or Other Format
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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
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Validation Service Options
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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)
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What EVERY Partner Should Know For Success
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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
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Recommendations For Success
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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
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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!