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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


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)?


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.


Empower Customers Empower Customers Empower Customers Empower Customers


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.


Current Model for Current Model for

lid i l i ilid i l i iValidation Consulting ServicesValidation Consulting Services


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


Example Customer EngagementExample Customer Engagementp g gp g g

Assessment / Finalize SOW

Standard Operating Procedure Development

Validation Plan



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


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


Future Approach for Empower 3 Future Approach for Empower 3


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


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.


Log on Screen Log on Screen ‐‐ Automated TechnologyAutomated Technology

Automated Technology


Test Selection ScreenTest Selection Screen


Summary ReportSummary Report

Automated Technology


Customer Engagement with AutomationCustomer Engagement with Automation



Validation Plan


S t C fi ti / D i S ifi ti



Custom Test Development

System Configuration / Design Specification

Summary Report

Execution


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


p

Manual 15 10 5

Automated 5 5 2

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