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Completing the Compliance PortfolioCompleting the Compliance PortfolioCompleting the Compliance PortfolioCompleting the Compliance Portfolio
Laura Turner
ESS Validation Services
©2010 Waters Corporation | COMPANY CONFIDENTIAL 1
TopicsTopics
History of Validation Consulting History of Validation Consulting
Validation ProcessValidation Process
Compliance Offering for Empower 3Compliance Offering for Empower 3
©2010 Waters Corporation | COMPANY CONFIDENTIAL 2
History of Expanding Validation ServicesHistory of Expanding Validation Services
Waters has always had off‐the‐shelf offerings for IQ/OQ of the Waters has always had off‐the‐shelf offerings for IQ/OQ of the Empower client installation.
—Manual Protocols or Qualification Workbooks
—Advanced Qualification Technology (AQT)
A gap remained…what about other aspects of Computer Systems Validation (CSV)?
©2010 Waters Corporation | COMPANY CONFIDENTIAL 3
History continued…History continued…
Over 10 years of experience supporting SDMS Over 10 years of experience supporting SDMS
To date we’ve worked with ~50 Empower customersTo date, we ve worked with 50 Empower customers
—30% New Customers / 70% Existing Customers
Established Quality Document Life Cycle process.
Certified Waters Product and Validation Specialists.
©2010 Waters Corporation | COMPANY CONFIDENTIAL 4
Empower Customers Empower Customers Empower Customers Empower Customers
©2010 Waters Corporation | COMPANY CONFIDENTIAL 5
Why is offering CSV services of value? Why is offering CSV services of value?
Allows customers to focus on their day‐to‐day activities.y y
Our assistance helps save time.p
Helps our customers to take fuller advantage of our technologies.
—Allowing them to adopt new systems, software and upgrades f tfaster.
©2010 Waters Corporation | COMPANY CONFIDENTIAL 6
Current Model for Current Model for
lid i l i ilid i l i iValidation Consulting ServicesValidation Consulting Services
©2010 Waters Corporation | COMPANY CONFIDENTIAL 7
Approach for a Configurable Product (Category 4)Approach for a Configurable Product (Category 4)
User Requirements Specification
RequirementsTesting
Functional Specification
FunctionalTesting
Specification Verification
Configuration Specification
ConfigurationTesting
Specification Verification
ConfiguredProduct
©2010 Waters Corporation | COMPANY CONFIDENTIAL 8
Example Customer EngagementExample Customer Engagementp g gp g g
Assessment / Finalize SOW
Standard Operating Procedure Development
Validation Plan
User Requirements Specification
Standard Operating Procedure Development
Custom Test Development
System Configuration / Design Specification
Summary Report
Execution
©2010 Waters Corporation | COMPANY CONFIDENTIAL
1 3 5 7 9 11 13 15
Time (Days)
Current Compliance Offering for EmpowerCurrent Compliance Offering for Empowerp g pp g p
IQ System (s)IQ Client (s)
OQ/PQ System (s)
AQT SQT
OQ Client (s)
Validation
Validation Plan Validation Summary
Services (CSV)
SOP Development Execution
©2010 Waters Corporation | COMPANY CONFIDENTIAL
VerificationSpecification
Services that support the Validation effortServices that support the Validation effort
On‐site and remote support as necessary.On site and remote support as necessary.
Review and update of deliverables (documents and tests).
Assistance with test case execution (if required) and training around test objective and prerequisites.—Typically customers like to execute the scripts themselves.
Project Management services for theProject Management services for the implementation/validation effort
©2010 Waters Corporation | COMPANY CONFIDENTIAL 11
Future Approach for Empower 3 Future Approach for Empower 3
©2010 Waters Corporation | COMPANY CONFIDENTIAL 12
Automated Compliance SuiteAutomated Compliance Suitepp
IQ System (s)AQT SQT
IQ Client (s)
OQ/PQ System (s)OQ Client (s)
Automated TechnologyTechnology
CSV Execution
CSV Verification
©2010 Waters Corporation | COMPANY CONFIDENTIAL
Rationale for AutomationRationale for Automation
Regulated Customers are required to perform Computer Regulated Customers are required to perform Computer System Validation.
Streamline test development and execution of tests.
Use existing tests from ESS Validation Services as basis for product.
Leverage existing development tools used at Waters today.
©2010 Waters Corporation | COMPANY CONFIDENTIAL 14
Rationale for AutomationRationale for Automation
Regulated Customers are required to perform Computer Regulated Customers are required to perform Computer System Validation.
Streamline test development and execution of tests.
Use existing tests from ESS Validation Services as basis for product.
Leverage existing development tools used at Waters today.
©2010 Waters Corporation | COMPANY CONFIDENTIAL 15
Log on Screen Log on Screen ‐‐ Automated TechnologyAutomated Technology
Automated Technology
©2010 Waters Corporation | COMPANY CONFIDENTIAL 16
Summary ReportSummary Report
Automated Technology
©2010 Waters Corporation | COMPANY CONFIDENTIAL 18
Customer Engagement with AutomationCustomer Engagement with Automation
Assessment / Finalize SOW
Standard Operating Procedure Development
Validation Plan
Assessment / Finalize SOW
S t C fi ti / D i S ifi ti
User Requirements Specification
Standard Operating Procedure Development
Custom Test Development
System Configuration / Design Specification
Summary Report
Execution
©2010 Waters Corporation | COMPANY CONFIDENTIAL 19
1 3 5 7 9 11 13 15
Time (Days)
Value of Automated Testing OptionValue of Automated Testing Option
On average, we hear that we are saving customers 25‐30% time. With an automated option we may see more like 50% time savingsWith an automated option, we may see more like 50% time savings for the overall project.
We estimate that automating tests will save 20‐50% time for execution.
Computer Systems Verification Testing
8
10
12
14
16
Days)
Development Review Execution0
2
4
6
Time (D
©2010 Waters Corporation | COMPANY CONFIDENTIAL 20
p
Manual 15 10 5
Automated 5 5 2