Validation 2.0 Streamlining Validation

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Validation 2.0Streamlining Validation

• Solution Overview

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Outline

• Validation 1.0 vs. Validation 2.0
• How can RCM help you get to Validation 2.0?
• Sample Validation 2.0 implementation

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Validation 1.0Where We Are

• Paper-based systemmany documents
• Validation Plan
• Requirements Document (User, Functional, Design
  )
• Test Scripts (IQ/OQ/PQ/FAT/SAT/UAT)
• Executed Test Scripts
• Lots of reports and screen shots
• Traceability Matrix (Links Requirements and
  Tests)
• Summary Report
• Nobody likes it
• Expensive
• Tedious
• Time-consuming
• We need an electronic alternative!

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The Vision for Validation 2.0

• An electronic system that manages each of the
  deliverables for a validation
• Improves control over the process
• Eliminates labor-intensive paper-based tasks
• Attaching screen-shots to test scripts
• Streamlines review and approval processes
• Reduces time and cost to comply with FDA
  requirements

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Use a Software Testing System!

• Application Lifecycle Management systems seem
  like an obvious fit
• Why is nobody is using them for CSV?
• The tools were designed for a different purpose
• The systems lack many of the workflow controls
  required in regulatory enviroments such as
  pharmaceuticals
• Systems can be expensive and hard to learn
• In order for these systems to be useful, they
  would have to be customized by someone who really
  knows the pharmaceutical industry and the tools

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You Need a Partner

• RCM is the logical partner
• RCM is an industry leader in Computer System
  Validation and understands the business
• RCM has extensive experience in specifying and
  implementing solutions for the pharma industry
• RCM can draw on its extensive resources in IT and
  engineering to support the solution
• RCM partners with several leading vendors
• Mercury
• Segue/Borland
• MKS
• ISG-Novasoft (Risk Management Compass)

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RCM Delivers

• Experts to help you select the proper testing
  solution
• Pharma-specific CSV add-ins for major testing
  packages to adapt them to pharma requirements
• Mercury
• Others as requested (Borland/Segue, MKS, etc.)
• Customization of our add-in to your process
• Validation services for the tool and add-ins
• Automated scripts to reduce implementation time
  and cost
• Perform the validation quickly and efficiently
• Experienced consultants to
• Train your staff
• Import existing requirements and tests to your
  new system
• Work on validation projects using the system

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A Validation 2.0 Implementation

• Mercury Quality Center is one way that a company
  could implement Validation 2.0
• Most widely used test-oriented Application
  Lifecycle Management system
• Well-known within the pharmaceutical industry
• Easiest tool to adapt to pharmaceutical use
• Lets see some sample screens from a Validation
  2.0 implementation of Quality Center

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Requirements

• Requirements are managed in a tree structure
• Quality Center tracks and numbers the requirement
• Add, revise, or rearrange as desired
• All changes are tracked (History tab)
• Review and approve electronically
• Enter requirements directly or import from Word
  or Excel documents

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Test Construction and Traceability

• Quality Center gives you a central location to
  create and manage all of your test scripts
  (manual or automated)
• Link the test to the requirement with one click
• Immediate traceability
• Maintain traceability even if requirements or
  tests change.
• Create tests in Quality Center or import from
  Word or Excel

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Test Execution

• One screen organizes all of the test execution
  activities
• Step number and name
• Date/time executed
• Status
• Directions
• Expected Result
• Actual Result
• Attachments to the test step
• Reports (1)
• Screen shots (2)
• Incident Reports (3)
• All results securely stored on server

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Improved Quality Review

• Tool prevents users from making major mistakes
• Stops tester from running test script unless
  requirements are approved
• Cannot run second test if first is not Passed
• Labor-intensive, low value tasks are eliminated
• All failed steps easily located
• No more reviewing attachments for
• Test number and step number reference
• Correct handwritten date and initials
• Handwritten page numbering
• Concentrate on reviewing incidents and insuring
  all incidents are closed