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MethodGXP. The Solution for the Confusion. Company’s Background. 20 years specializing in Quality Assurance, Software Engineering and IT Management 10 years specializing in Software Validation 60 Senior Consultants (at least 10Y experience)

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The Solution for the Confusion

company s background
Company’s Background
  • 20 years specializing in Quality Assurance, Software Engineering and IT Management
  • 10 years specializing in Software Validation
  • 60 Senior Consultants (at least 10Y experience)
  • Leading methodology and knowledgebase for software engineering and IT management
  • Quality certification for ISO-9001
  • Proven methodology for the FDA regulations
the challenges
The Challenges
  • Complexness to achieve qualitative product and processes
  • The need to be compliant with different standards and regulations (CE, FDA, ISO, etc)
  • Many guides for similar and complementary requirements
  • Much confusion and unclear instructions
  • Potential for duplication in documents, processes and activities 
too many guides

Design Control Guidance

General Principle of SW Validation

OTS Software

GeneralPrinciples of Process Validation


Pre-market Submissions

ISO 9000 ISO 13485

21 CFR Part 11


Too many Guides
main requirements
Main Requirements
  • "Any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use..“
  • "Software validation activities may occur both during, as well as at the end of the software development life cycle to ensure that all requirements have been fulfilled."
  • "A conclusion that software is validated is highly dependent upon comprehensive software testing, inspections, analyses, and other verification tasks performed at each stage...“
  • “Establish DOCUMENTED EVIDENCE that provides a HIGH DEGREE of assurance that a computer system or software will CONSISTENTLY perform within its predetermined specifications and quality attributes.”
21 cfr part 11 more requirements and challenges
21 CFR Part 11- More requirements and challenges
  • “.. computer systems used to create, modify, and maintain electronic records and to manage electronic signatures are also subject to the validation requirements.“
  • “… FDA will consider electronic recordsto be equivalent to paper records, and electronic signatures equivalent to traditional handwritten signatures.”
  • Ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records.... ensure that the signer cannot readily repudiate the signed record as not genuine.”
summary of challenges
Summary of Challenges
  • Overload of information and instructions
  • Compliance with the regulations is essential
  • Advanced methodology is required for reduced risks and business efficiency

Pragmatic solution is required!

pragmatic solution a risk based approach
Pragmatic solution - A risk based approach

A risk based approach will be acceptable, but how do you legally justify your risk assessment?

  • “General Principles of Software Validation, Draft Guidance Version 1.1”

“…The resultant software validation process should be commensurate with risk associated with system, device or process”

pragmatic solution a risk based approach1
Pragmatic solution - A risk based approach
  • Pre-Market:

“..risk estimation for software products should be based on the severity of the hazard resulting from failure...”

  • GPOSV:

"The magnitude of software validation effort should be commensurate with the risk associated with the device….“

  • GAMP 4:

The categories are based on the increasing risk of system failure with the progression from standard SW and HR to custom…”

methoda s risk based approach
Methoda’s Risk Based Approach

Pragmatic Solution


Risk Based Approach

Severity & Category

Part 11 Priorities & Efforts

Validation Efforts

methoda s risk based approach1
Methoda’s Risk Based Approach
  • Risk will be determined by assessing:
    • The Level of Concern to determine the level of the validation activities
    • The complexity/category of the system to determine the validation deliverables
criteria for the appropriate solution
Criteria for the Appropriate Solution
  • Business efficiency - Quality product and development process
  • Receiving the right information (and terminology) to support submissions
  • Integration of all regulatory requirements
  • Elimination of duplication- globally aligned system eliminates unique local requirements
  • Cost effective solution
methodgxp the solution
MethodGxP - The Solution
  • Tool-Kit that is ready for implementation
  • Single Standard Quality System that complies with the QSR, ISO, and CE Mark
  • Comprehensive procedural framework
  • Solution life cycle supports good engineering practice
  • Policy that supports compliance with requirements and regulations
methodgxp the solution1
MethodGxP - The Solution
  • Comprehensive Risk Management process to minimize the requirements
  • Efficiency and NO duplications


validation tasks
Validation Tasks
  • System Mapping
  • Gap Analysis
  • Policy
  • Work Plan for closing the gaps
  • Validation Deliverables: VP, IQ, OQ, PQ, TM, VSR and vendor documented evidences
  • Maintenance of system
  • Periodic Review
validation life cycle

System Validation Plan

Validation Summary Report

Performance Qualification

User Requirements



Operational Qualification



Installation Qualification


Validation Life Cycle
process recap methodgxp advantages
Process Recap - MethodGxP Advantages
  • Cost effective solution
  • Simple and efficient model
  • Single Checklist
  • Easy to understand - easy to use
  • Compliant with the regulations
  • Comprehensive solution from concept to maintenance
process recap methodgxp advantages1
Process Recap - MethodGxP Advantages
  • A proper Implementation of MethodGxP results in:
    • Improved system quality
    • Meeting Goals, Schedule and Budget
    • Improving Cost/Performance
    • Control & Management
    • Satisfied User
phase 1 gap analysis
Phase 1 - Gap Analysis
  • Determining the actions needed to bring the system into compliance with established software validation and 21 CFR Part 11 regulations
  • Input: Regulation requirements and systems’ gaps
  • Output: Action items to close the gaps – Gap analysis template
phase 2 policy
Phase 2 - Policy
  • Based on Risk Based Approach
  • Specifiesall validation activities for all regulated computer systems
  • Input: FDA requirements, good engineering practice
  • Output:Policy document
phase 3 work plan
Phase 3 - Work Plan
  • Detailed action items for each system with priorities and required recourses
  • Input: Gap analysis and Policy
  • Output: Work plan
phase 4 validation
Phase 4 - Validation
  • Deliverables and Activities:
    • Validation Plan
    • User Requirements Specification
    • Installation Qualification
    • Operational Qualification
    • Performance Qualification
    • Testing Execution
    • Traceability Matrix
    • Validation Summary Report
  • Input: Policy
  • Output: Validated systems
phase 5 training
Phase 5 - Training
  • To ensure reliable system operation
  • To ensure reliable procedures operation
  • Input: User guide, SOPs
  • Output: Trained users
phase 6 software validation maintenance
Phase 6 - Software Validation Maintenance
  • Any change to equipment and computer systems that may affect the system’s validation status should follow documented procedures and should be formally approved
  • Input: Changes
  • Output: Validated systems
phase 7 periodic review
Phase 7 - Periodic Review
  • Periodic reviews will be performed and documented for each validated system to ensure its validation status is still current
  • Input: System status
  • Output: Validated systems
step 8 system retirement
Step 8 - System Retirement
  • Disposition of system software
  • Disposition of system documentation
  • Migration (if necessary) or archiving of data
  • Input: Retired System
  • Output: Historical data that can be retrieved