Www.methoda.com MethodGXP The Solution for the Confusion.

www.methoda.com

MethodGXPMethodGXP

The Solution for the ConfusionThe Solution for the Confusion

2Methoda Computers Ltd

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

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

21

CFR Part 11

General Principle of SW Validation

OTS Software

GeneralGeneral PrinciplesPrinciples of Process Validation of Process Validation

ISO 9000 ISO 13485

Pre-market

Submissions

GAMP 4

cGMP-QSR


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

“.. 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 records to 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

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 is required!Pragmatic solution is required!Pragmatic solution is required!


Pragmatic solution - A risk based approach

GAMP IV

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 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

Pragmatic Solution

Policy

Risk Based Approach

Severity & Category

Validation EffortsPart 11 Priorities & Efforts


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

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

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 Solution

Comprehensive Risk Management process to minimize the requirements

Efficiency and NO duplications

DO IT RIGHT the FIRST TIMEDO IT RIGHT the FIRST TIMEDO IT RIGHT the FIRST TIMEDO IT RIGHT the FIRST TIME


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

User Requirements

FunctionalSpecifications

Design Qualification

Performance Qualification

Operational Qualification

Installation Qualification

Installation

System Validation Plan

Validation Summary Report


Example of GXP Validation Folder


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 Advantages

A proper Implementation of MethodGxP results in:

Improved system quality Meeting Goals, Schedule and Budget Improving Cost/Performance Control & Management Satisfied User


GxP Implementation Plan for the pharmaceutical market

Activity

Gap analysis

Policy

Work plan

Validation

Training

Software Validation maintenance Periodic review

System retirement


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

Gap analysis

Policy

Work plan

Validation

Training


System retirement


Phase 2 - Policy

Based on Risk Based Approach

Specifies all validation activities for all

regulated computer systems

Input: FDA requirements, good engineering practice

Output: Policy document

Gap analysis

Policy

Work plan

Validation

Training


System retirement


Phase 3 - Work Plan

Detailed action items for each system with priorities and required recourses

Input: Gap analysis and Policy

Output: Work plan

Gap analysis

Policy

Work plan

Validation

Training


System retirement


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 4 - Validation

Gap analysis

Policy

Work plan

Validation

Training


System retirement


Phase 5 - Training

To ensure reliable system operation To ensure reliable procedures operation

Input: User guide, SOPs Output: Trained users

GAP Analysis

Policy

Work Plan

Validation

Training


System retirement


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

Gap analysis

Policy

Work plan

Validation

Training


System retirement


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

Gap analysis

Policy

Work plan

Validation

Training


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

Gap analysis

Policy

Work Plan

Validation

Training


System retirement


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