Qualification Verification Template

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					                          Validation and Verification:
                          Practical Process and Planning



                              Barbara Johnson
                              Clarkston Consulting

                              December 4, 2007




Agenda

 Practical Validation

 Plan the Work, Work the Plan

 Good Process Development and Planning for Validation

 Challenges of Quality Implementation and System
 Validation




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                                Practical Validation




Practical Approach

 Risk Based Approach
  • Pick a method and rationalize it


 Common Methodology
  • Overall CSV Methodology
  • Overall IPQ Methodology


 Structured Governance
  • Policies, Procedures, Processes and Practices


 Operational Excellence
  • Apply business concepts to IT


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Risk Based Approach to V&V

     Based on industry, business, product

     Criticality of operations and system functionality

     External factors – system stability, regulatory history




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Computer System Validation Methodology

                                 Phased CSV Deliverables and Activities




 • Assessment of Current          • User Requirements                                • Validation Test Plan                             • Validation Final Report
   Validation Procedures            Specifications documented                          developed                                          issued
 • Validation Determination       • Functional Specifications                        • Installation Qualification                       • System Released for
   Statement                        documented                                         Protocol developed and                             Productive Use
                                                                                       executed
 • Validation Plan issued         • Compliance Criticality Risk                                                                         • System under change
                                    Assessment conducted and                         • Operational Qualification                          control and problem
 • Vendor Audit(s) and Audit
                                    documented                                         Protocol developed and                             reporting
   Reporting (when applicable)
                                                                                       executed
                                  • Design Specifications                                                                               • On-going training occurs as
 • Validation Project Plan
                                    documented                                       • Performance Qualification                          required
   created and integrated with
                                                                                       Protocol developed and
   overall Project Plan(s)        • Software Configuration                                                                              • Legacy Systems Retired (if
                                                                                       executed
                                    Specification Description                                                                             Applicable)
                                    documented                                       • Qualification Final Reports
                                                                                       issued after the execution of
                                  • Initial Requirements Trace
                                                                                       each protocol
                                    Matrix developed
                                                                                     • Final Trace Matrix issued




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From Protocol to Procedure




                                                                       Policy                                    SOP’S




       Protocol Based                                                                             Procedure
        Methodology                                                                                 Based
                                                                                                 Methodology


                                                                 Templates                                         Forms




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Governance Building Blocks




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                             Plan the Work, Work the Plan




Validation Planning

  Strategic Organization to align and support Tactical
  initiatives

  Before developing and executing any Validation Plan, it is
  imperative to implement a CSV methodology

  People, process and tools to execute effectively and
  efficiently

  Cross-Functional Team – specific roles and
  responsibilities


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Computer Systems Validation Planning




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Computer System Validation Methodology

                                                   Commence Phase




 • Assessment of Clients         • User Requirements                                • Validation Test Plan                             • Validation Final Report
   Validation Procedures           Specifications documented                          developed                                          issued
 • Validation Determination      • Functional Specifications                        • Installation Qualification                       • System Released for
   Statement                       documented                                         Protocol developed and                             Productive Use
                                                                                      executed
 • Validation Plan issued        • Compliance Criticality Risk                                                                         • System under change
                                   Assessment conducted and                         • Operational Qualification                          control and problem
 • Vendor Audit(s) and Audit
                                   documented                                         Protocol developed and                             reporting
   Reporting (when applicable)
                                                                                      executed
                                 • Design Specifications                                                                               • On-going training occurs as
 • Validation Project Plan
                                   documented                                       • Performance Qualification                          required
   created and integrated with
                                                                                      Protocol developed and
   overall Project Plan(s)       • Software Configuration                                                                              • Legacy Systems Retired (if
                                                                                      executed
                                   Specification Description                                                                             Applicable)
                                   documented                                       • Qualification Final Reports
                                                                                      issued after the execution of
                                 • Initial Requirements Trace
                                                                                      each protocol
                                   Matrix developed
                                                                                    • Final Trace Matrix issued




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Computer System Validation Methodology

 Commence Phase
 Prepare for the project by defining all critical components which assist in the planning and
 execution of the implementation.
 Culminates with the creation of schedules and plan documents for the development of
 further project phases as well as inventory of data requirements.

  Deliverables                                                                         Tools

  •   Current CSV Assessment                                                           •   Validation Determination Statement Template
  •   Validation Determination Statement                                               •   Validation Plan Template
  •   Validation Plan                                                                  •   Vendor Audit Report Template
  •   Vendor Audit Report (if required)                                                •   Validation Project Plan Template
  •   Validation Project Plan




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Computer System Validation Methodology

                                                       Architect Phase




 • Assessment of Clients         • User Requirements                                • Validation Test Plan                             • Validation Final Report
   Validation Procedures           Specifications documented                          developed                                          issued
 • Validation Determination      • Functional Specifications                        • Installation Qualification                       • System Released for
   Statement                       documented                                         Protocol developed and                             Productive Use
                                                                                      executed
 • Validation Plan issued        • Compliance Criticality Risk                                                                         • System under change
                                   Assessment conducted and                         • Operational Qualification                          control and problem
 • Vendor Audit(s) and Audit
                                   documented                                         Protocol developed and                             reporting
   Reporting (when applicable)
                                                                                      executed
                                 • Design Specifications                                                                               • On-going training occurs as
 • Validation Project Plan
                                   documented                                       • Performance Qualification                          required
   created and integrated with
                                                                                      Protocol developed and
   overall Project Plan(s)       • Software Configuration                                                                              • Legacy Systems Retired (if
                                                                                      executed
                                   Specification Description                                                                             Applicable)
                                   documented                                       • Qualification Final Reports
                                                                                      issued after the execution of
                                 • Initial Requirements Trace
                                                                                      each protocol
                                   Matrix developed
                                                                                    • Final Trace Matrix issued




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                                        Reproduction by any method or unauthorized circulation is prohibited without prior approval.                                   14
Computer System Validation Methodology

Architect Phase
Finalize the business processes and creation of the detailed plan to implement the Quality
System.
This is based largely on the results of the Commence Phase with updated scope determined
by the ‘To-Be’ Processes.

  Deliverables                                                                          Tools
  •   User Requirements Specifications                                                  • User Requirements Specifications Template
  •   Functional Specifications                                                         • Functional Specifications Template
  •   Compliance Criticality Risk Assessment                                            • Compliance Criticality Risk Assessment Template
  •   Design Specifications                                                             • Design Specifications Template
  •   Software Configuration Specifications Description                                 • Software Configuration Specifications Description
  •   Requirements Trace Matrix (initial)                                                 Template
                                                                                        • Requirements Trace Matrix Template




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                                        Reproduction by any method or unauthorized circulation is prohibited without prior approval.                                   15




Computer System Validation Methodology

                                                             Build Phase




 • Assessment of Clients         • User Requirements                                • Validation Test Plan                             • Validation Final Report
   Validation Procedures           Specifications documented                          developed                                          issued
 • Validation Determination      • Functional Specifications                        • Installation Qualification                       • System Released for
   Statement                       documented                                         Protocol developed and                             Productive Use
                                                                                      executed
 • Validation Plan issued        • Compliance Criticality Risk                                                                         • System under change
                                   Assessment conducted and                         • Operational Qualification                          control and problem
 • Vendor Audit(s) and Audit
                                   documented                                         Protocol developed and                             reporting
   Reporting (when applicable)
                                                                                      executed
                                 • Design Specifications                                                                               • On-going training occurs as
 • Validation Project Plan
                                   documented                                       • Performance Qualification                          required
   created and integrated with
                                                                                      Protocol developed and
   overall Project Plan(s)       • Software Configuration                                                                              • Legacy Systems Retired (if
                                                                                      executed
                                   Specification Description                                                                             Applicable)
                                   documented                                       • Qualification Final Reports
                                                                                      issued after the execution of
                                 • Initial Requirements Trace
                                                                                      each protocol
                                   Matrix developed
                                                                                    • Final Trace Matrix issued




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                                        Reproduction by any method or unauthorized circulation is prohibited without prior approval.                                   16
Computer System Validation Methodology

 Build Phase
 Execution of the detailed plan from the Architect phase including SOPs, Custom
 configuration, Validation Testing, Training, and Master Data as necessary to achieve
 requirements for roll-out.



  Deliverables                                                                         Tools
  •   Validation Test Plan                                                             •   Validation Test Plan Template
  •   Installation Qualification Protocol                                              •   IQP Template
  •   Operational Qualification Protocol                                               •   OQP Template
  •   Performance Qualification Protocol                                               •   PQP Template
  •   Qualification Protocol Final Report                                              •   QPFR Template
  •   Trace Matrix                                                                     •   Trace Matrix Template




                                                            Clarkston Consulting Confidential and Proprietary
                                        Reproduction by any method or unauthorized circulation is prohibited without prior approval.                                   17




Computer System Validation Methodology

                                                      Transition Phase




 • Assessment of Clients         • User Requirements                                • Validation Test Plan                             • Validation Final Report
   Validation Procedures           Specifications documented                          developed                                          issued
 • Validation Determination      • Functional Specifications                        • Installation Qualification                       • System Released for
   Statement                       documented                                         Protocol developed and                             Productive Use
                                                                                      executed
 • Validation Plan issued        • Compliance Criticality Risk                                                                         • System under change
                                   Assessment conducted and                         • Operational Qualification                          control and problem
 • Vendor Audit(s) and Audit
                                   documented                                         Protocol developed and                             reporting
   Reporting (when applicable)
                                                                                      executed
                                 • Design Specifications                                                                               • On-going training occurs as
 • Validation Project Plan
                                   documented                                       • Performance Qualification                          required
   created and integrated with
                                                                                      Protocol developed and
   overall Project Plan(s)       • Software Configuration                                                                              • Legacy Systems Retired (if
                                                                                      executed
                                   Specification Description                                                                             Applicable)
                                   documented                                       • Qualification Final Reports
                                                                                      issued after the execution of
                                 • Initial Requirements Trace
                                                                                      each protocol
                                   Matrix developed
                                                                                    • Final Trace Matrix issued




                                                            Clarkston Consulting Confidential and Proprietary
                                        Reproduction by any method or unauthorized circulation is prohibited without prior approval.                                   18
Computer System Validation Methodology

 Transition Phase
 Rollout of the completed and validated Quality System by business function or area.
 This also includes detailing the requirements for future support and enhancement.




 Deliverables                                                                 Tools
 • On-going Training (Long term training                                      • Training After Go-Live Card
   plan required)                                                             • Lessons Learned Summary Report
 • Detailed Cutover Plan                                                      • Project Close-Out Template
 • Lessons Learned Summary Report
 • Support Procedures
 • Business Benefit Reporting in place
 • Project Close-out Plan
 • Change Acceptance Survey




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                                          Good Process Development and
                                          Planning for Validation
Overall Compliance Program




                                                                                                         Consistent approach
                                                                                                         Integrated teams
                                                                                                         Concise communications
                                                                                                         Teams to leverage standards &
                                                                                                         Best Practices
                                                                                                         Effective knowledge transfer
                                                                                                         Maximize the probability of
                                                                                                         success




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V&V Program Management Office – Benefits

Life Sciences companies need to take a multi-disciplinary approach towards executing
complex programs. Within a regulated company, a group of individuals must be made
responsible for marshalling an organization’s resources to achieve an objective. The
processes and project tracking data are collectively used to manage the delivery of
business value on time and within budget. Most importantly, a PMO applies the
experiences from other programs to maximize the probability of success.


  Without a PMO                                                                        With a PMO
     Resources get pulled in multiple different                                               Resources are focused on specific tasks
     directions.                                                                              and priorities.
     Priorities are set and managed to at the                                                 Priorities are set and managed to at the
     micro level.                                                                             macro level.
     Progress can not be monitored in a                                                       Progress is tracked such that expectations
     uniform, logical fashion.                                                                are set and managed.
     V&V methods are not consistently                                                         V&V solutions are uniform across the
     applied.                                                                                 organization.
     Results are not easily defensible.                                                       Results are easily defensible.




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Benchmarking Using a Maturity Model


        Non-
       Existent       Initial           Repeatable                       Defined                     Managed                Optimized
          0              1                         2                            3                            4                 5



          Legend for Rankings Used
          0 Non-Existent - Management processes are not applied at all
          1 Initial          - Processes are ad-hoc and disorganized
          2 Repeatable       - Processes follow a regular pattern
          3 Defined          - Processes are documented and communicated
          4 Managed          - Processes are monitored and measured
          5 Optimized        - Best practices are followed and automated


   COBIT 3 Model - Control Objectives for Information and Related Technology

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                                       Challenges of Quality
                                       Implementation and System
                                       Validation
IT in the Regulated Industry - Challenges
 Operational: Need to address the volatile regulatory concerns along
 with the constant pressure of a demanding Supply Chain.

 IT as a Utility – client expectations on the rise

 Organizational: Quality organization versus IT

 Forced to pursue flexible solutions often against imposed deadlines.
   • External commitments (FDA, EMEA, etc) & internal commitments
     (Corporate and Third-Party Audits)

 Variety of quality-related business processes managed within various
 manual and automated systems.
   • ‘Non-standard’ deliverables and methodologies
   • Delayed implementations, decreased compliance position
   • Sub-optimal information sharing among systems


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Information Industry Challenges

 System Trends
   • Complexity
   • Pervasiveness
   • Inter-operability

 Automated Testing Tools

 Hardware Independence
   • Portability


 Off-shore resourcing
 Separating GxP vs. Non-GxP
 SDLC vs. SDIM or SILC

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Proactive vs. Reactive Approach

 Regulated companies can gain tremendous benefit from
 standardization and integration of quality-related business
 processes into holistic, proactive validation programs.

 By laying out a strategy to improve processes and
 implement enabling technologies in a proactive manner
 companies will be able to:
  •   Increase overall quality in testing and documentation
  •   Increase efficiency of processes
  •   Reduce cost and re-work
  •   Decrease timeline & total cost of implementation
  •   Increase consistency in approach
  •   Increase audit preparedness

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Balancing Act

 Challenge
  • Balance operational efficiency with sustainable compliance in a
    dynamic environment
 Impact
  • FDA’s new operating paradigm demands a higher level of
    enterprise-wide consistency across Quality Systems. Companies
    are focusing on continuous process improvement and Quality by
    Design. Misalignment in these areas can result in increased
    scrutiny by the agency and protracted inspections – cost and
    resources.
 Message
  • Adopting a proactive approach to V&V can help mitigate risk,
    decrease the likelihood of warning letters, improve your
    operational efficiency, embrace compliance, and dramatically
    improve your bottom line.


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The Roadmap to Best Practice

      System Validation               STANDARDS AND OPERATING NORMS                                                                                                                                  Validation Program


   Identification




                                                                                                               SARBANES – OXLEY ACT

                                                                                                                                      OSHA – EPA – EOC - PRIVACY

                                                                                                                                                                   COBIT-ITIL-COSO-IS0-TICKIT
    Interpretation                                                                                                                                                                              Policies                  Standards




                                       MARKET AND CUSTOMER STANDARDS

                                                                        FDA REGULATIONS & GUIDELINES

                                                                                                       HIPAA
       Impact




                                                                                                                                                                                                             Processes
    Investment ?




      Integration                                                                                                                                                                                            Procedures




    Implementation                                                                                                                                                                              Training                    Tools


                          Mapping of Validation Requirements to Policies, Processes and Procedures



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                                                                        Thank you!

                                                                       Barbara Johnson
                      bjohnson@clarkstonconsulting.com




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                                     Reproduction by any method or unauthorized circulation is prohibited without prior approval.                                                                                                   30

				
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