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Costeffective validation

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Costeffective validation – PowerPoint PPT presentation

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Title: Costeffective validation


1
Cost-effective validation
2
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!

3
Stakeholders
4
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

5
Central, qualified infrastructure
Infra- structure Qualification
LIMS
ERP
CLIN
EDMS
LIMS Validation
ERP Validation
CLIN Validation
EDMS Validation
6
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

7
Computer Validation Model
Elaboration/ Construction
Inception
Transition
endor management
Validation report
Validation plan
V
User requirements specification
.
Performance qualification
.
.
Installation qualification
.
T
ime
8
Computer Validation Model
Elaboration/ Construction
Inception
Transition
endor management
Validation report
Validation plan
V
User requirements specification
.
Performance qualification
.
.
Installation qualification
.
T
ime
9
Computer Validation Model
Elaboration/ Construction
Inception
Transition
endor management
Validation report
Validation plan
V
User requirements specification
.
Performance qualification
.
.
Installation qualification
.
T
ime
10
Customisation
increased validation cost
Validation cost vs Fit to business
Cost/Fit
Validation
Cost
Fit to
Business
Customisation
Standard system
11
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

12
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

13
Generic validation documents - example
14
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

15
Risk Analysis - example
16
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

17
The right tools reduces effort
18
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

19
Configuration management tools
20
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

21
Test Management
Test planning
Requirements management
Electronic signature
Analysis
Customisation
Reporting
Defect registration
Test execution
Import / export
22
Test Plan and Test Cases
23
Defects
24
Electronic signature
Testcases are approved with electronic signature
21 CFR part 11 compliant
Approval
Audit trail
25
Reporting
Progress Test execution
Defectreporting
Requirementscoverage
26
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

27
Preparing automatic test scripts
28
Viewing test results
29
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

30
Resource load factors
Construction
Transition
Inception
Analysis
Design
Test
Project management
Business analyst/architect
Developer
Validation manager/tester
31
Contact
tot_at_nnit.com
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