These documents are typically developed and approved prior to initiating any validation execution activities.

The cost for each customized document varies depending upon the complexity of the isolator or isolator system.

User Requirements Specification

This document is developed to establish minimum requirements from the user’s perspective. This document is the basis for future specification efforts, validation protocols, and for developing estimates of cost and delivery of an installed system.

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TABLE OF CONTENTS

System Impact Assessment

This document provides documented evidence whether or not the isolator is a direct or indirect impact system and provides the basis for future efforts and validation protocols.

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TABLE OF CONTENTS

Component Criticality Assessment

This document assess all isolator components (electrical, pneumatic, mechanical, etc.) and determines whether or not they are classified as critical or non-critical. This information provides the basis for future validation protocols and the maintenance plan.

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TABLE OF CONTENTS

Enhanced Design Review

This document is used to describe the process by which engineering designs for the isolator are evaluated and determined to be non-critical or critical. This document is also an elaborate traceability matrix that identifies where each User Requirement Specification is verified.

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TABLE OF CONTENTS

Risk Assessment

The purpose of this document is to identify vulnerabilities, likelihood of failure and the potential damage that can occur, and summarizes the possible defensive measures to be implemented as it relates to the isolator.

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TABLE OF CONTENTS

Validation Master Plan

The purpose of this document is to define and describe the scope, key objectives, activities, and resources for the validation of an isolator. It is a requirement of CGMP to identify what qualification and validation work is required to prove control of the critical aspects of the isolator.

To view this document's example Table of Contents, click the link below:

TABLE OF CONTENTS