Costeffective validation

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Cost-effective validation
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Cost-effective validation

• Central, qualified platforms and infrastructure
• Standard software from qualified vendors
• Generic validation documents
• Risk based approach
• Tools to reduce paper
• Dedicated validation managers
• Its that simple..really!

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Stakeholders
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Central, qualified infrastructure

• Install applications on servers databases
  qualified and operated by central IT centre
• They are the experts
• Standard Operating Procedures
• Economies of scale
• Advantages of central, qualified infrastructure
• No need for you to prepare your own documents
• Reference to central documents. They are off-the
  shelf, eg
• Infrastructure/platform specifications,
  Configuration Item Lists
• SOPs for configuration mgt., operation, backup
  etc
• IQ and OQ protocols and test cases
• Changes to platforms only documented and tested
  once, eg
• Service packs and security patches

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Central, qualified infrastructure
Infra- structure Qualification
LIMS
ERP
CLIN
EDMS
LIMS Validation
ERP Validation
CLIN Validation
EDMS Validation
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Pre-qualified standard software

• Implement pre-qualified standard software if
  possible
• It may reduce your validation effort
  significantly
• Often based on current best practice
• Pre-requisites
• Audit early in the process
• Vendor QMS must comply with regulatory
  requirements for computer validation
• Vendor must have well-documented specifications
  and test
• Adapt or optimise your processes to fit the
  standard system
• It may be easier to change your process to fit a
  mature standard application than it is to force
  the system to fit your process
• Reduction in validation effort
• Reduce your efforts regarding Specification, IQ,
  OQ, etc, by referring to Vendor Specification and
  Qualification

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Computer Validation Model
Elaboration/ Construction
Inception
Transition
endor management
Validation report
Validation plan
V
User requirements specification
.
Performance qualification
.
.
Installation qualification
.
T
ime
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Computer Validation Model
Elaboration/ Construction
Inception
Transition
endor management
Validation report
Validation plan
V
User requirements specification
.
Performance qualification
.
.
Installation qualification
.
T
ime
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Computer Validation Model
Elaboration/ Construction
Inception
Transition
endor management
Validation report
Validation plan
V
User requirements specification
.
Performance qualification
.
.
Installation qualification
.
T
ime
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Customisation
increased validation cost
Validation cost vs Fit to business
Cost/Fit
Validation
Cost
Fit to
Business
Customisation
Standard system
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Generic validation documents

• Use generic validation documents
• Dont start with a blank paper
• Use templates or even better .
• Generic documents with most text filled out, e.g.
  
• roles, responsibilities, definitions
• purpose and description of IQ, OQ etc.
• Generic documents will give you
• Uniform documents across all IT systems
• Better quality documents
• Speed up the process
• Ease of understanding, review and approval

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Generic validation documents - example

• Responsibilities and Roles
• System owner
• The system owner shall ensure
• The system is compliant with regulatory
  requirements
• Validation of the system is performed
• Organisation of the implementation and validation
  project
• System access control and security meets
  requirements
• Users of the system have been trained
• Project Manager
• The project manager shall ensure
• Necessary resources are available for the project
• The system is installed in a proper way
• The system is validated in a proper way i.e.
  living up to internal validation demands
• A validation responsible is appointed
• Any consultants participating in the project are
  properly trained
• The resources for the validation activities are
  available e.g. the validation project are
  supported by the management
• Validation Responsible
• The validation responsible shall ensure
• Compliance with appropriate regulatory, business,
  technical and user community requirements

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Generic validation documents - example
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Risk Based Validation

• Risk based approach
• Can reduce validation cost
• Only do risk analysis if the savings exceed the
  cost of risk analysis
• Base risk analysis on GAMP 4 categories
• Different levels of risk analysis dependant on
  GAMP category
• Different levels of risk analysis during the
  project phases
• Initial phase Identify GxP modules and function
• Design Phase Identify GxP critical record and
  control
• Test fase Identify different levels of testing

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Risk Analysis - example
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Right tools paperless validation

• Typical tools for configuration management and
  test are Excel spreadsheets and Word documents
• Most project and test managers will recognise the
  following time consuming challenges
• Breakdown of Excel and Word documents when they
  become too large
• Difficult to find and reuse documents on file
  servers
• Paper copies of test cases and test result are
  lost, mislaid or someone else took the print by
  mistake
• Distribution logistics of test cases and test
  results when test takes place at more sites

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The right tools reduces effort
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Configuration management tools

• Regulatory requirement for validated IT solutions
• Change control and configuration management
• Accurate Configuration Item List and
  configuration baseline reviews
• Advantages of configuration management tools
• Central repository including backup, access and
  version control
• All configuration actions are registered in the
  same way every time
• Standardised Configuration Item List
• Easy reference to other components
• Easy reporting when creating baselines
• All configuration actions will be traceable
• The right tool is 21 CFR Part 11 compliant
• Audit trail registers when a configuration has
  been made and by whom

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Configuration management tools
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Paperless test

• Good test management tools
• Easy and efficient
• Traceability to requirements
• Test planning
• Test execution
• Defects handling
• Test coverage and defect reporting
• Prerequisites
• Electronic signature
• Audit trail
• Benefits
• Reduces test execution effort up to 50

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Test Management
Test planning
Requirements management
Electronic signature
Analysis
Customisation
Reporting
Defect registration
Test execution
Import / export
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Test Plan and Test Cases
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Defects
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Electronic signature
Testcases are approved with electronic signature
21 CFR part 11 compliant
Approval
Audit trail
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Reporting
Progress Test execution
Defectreporting
Requirementscoverage
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Automated test

• Test Automation tools can
• reduce need for test resources
• make test execution more efficient
• Most benefits achieved in
• Regression test of changes/upgrades to
  application
• Roll out to more sites
• Regression test in relation to patch upgrades on
  platforms.
• Informal dry-run
• Load of test data into test environment
• Challenges
• Test script must be robust, eg accept minor
  changes to user interface, naming of labels
• QA reviewers must be able to read test
  script/code
• Still not broadly accepted by QA people

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Preparing automatic test scripts
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Viewing test results
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Validation manager

• Best practice is to establish a project
  organisation which includes a role as validation
  manager
• This role is just as important as that of project
  manager, system architect, business analyst, lead
  developer, developer and tester
• The role of the validation manager is to
• Support the project manager in implementing a
  validated system meeting customer as well as
  regulatory requirements
• Plan, execute or supervise all validation
  activities
• E.g. validation planning, document review,
  traceability matrix, IQ, OQ and PQ preparation
  and execution, and validation reporting
• A Validation manager raises compliance and
  reduces effort and cost
• reduces review iterations and QA approval effort
• reduces overall validation resource load

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Resource load factors
Construction
Transition
Inception
Analysis
Design
Test
Project management
Business analyst/architect
Developer
Validation manager/tester
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Contact
tot_at_nnit.com