Installation qualification of IBM systems and storage for FDA regulated companies / [James R. Bradburn, William F. Drury, Mark Steele].

Format:

Book

Author/Creator:

Bradburn, James R.

Contributor:

International Business Machines Corporation. International Technical Support Organization

Drury, William F.

Steele, Mark.

Series:

IBM redbooks.

Redbooks

Language:

English

Subjects (All):

Drug development--United States--Computer programs.

Drug development.

Drugs--United States--Testing--Computer programs.

Drugs.

United States. Food and Drug Administration.

United States.

Physical Description:

1 online resource (460 p.)

Edition:

1st ed.

Place of Publication:

[Auston, Texas] : International Technical Support Organization, c2003.

Language Note:

English

Contents:

Front cover

Contents

Notices

Trademarks

Preface

Assumptions and other key points to consider

The team that wrote this redbook

Become a published author

Comments welcome

Qualification Plan

Document approval

Change history

Part 1 Qualification Plan information

Chapter 1. Introduction

1.1 Scope

1.2 Structure of the Qualification Package

1.3 Acceptance criteria

1.4 Roles and responsibilities

1.4.1 Management roles

1.4.2 Qualification and project team roles

Chapter 2. Infrastructure description

2.1 Technical design documents

2.2 Infrastructure identification/Inventory list

2.3 Equipment Environmental requirements

2.4 Infrastructure (equipment) functional description

Chapter 3. Installation qualification preparation

3.1 Validation team training

3.1.1 General Regulatory Training/21CFR11 basics

3.1.2 Good Documentation Practices training

3.1.3 Qualification Plan/Protocol training

3.1.4 Testing Procedures training

3.2 Validation Team training/Qualifications Records

3.3 Signature Log

3.4 Installation manuals and procedures

Chapter 4. Risk assessment

4.1 Risk identification

4.2 Risk mitigation

4.3 Applying risk to the testing protocol

Chapter 5. Testing protocol

5.1 Protocol contents

5.2 Roles and responsibilities

5.3 Infrastructure installation/Configuration verification

5.4 Environmental conditions verification

5.5 Documentation verification

5.6 Infrastructure functions verification

5.7 Trace Matrix

5.8 Test script preparation, approval, and changes

5.9 Test execution

5.10 Test testing protocol and Qualification Plan deviations

5.11 Test Report

Chapter 6. Equipment operations and support procedures

6.1 Physical security

6.2 Change control/Configuration management

6.3 Backup and restore.

6.4 Infrastructure monitoring

6.5 Periodic/Preventative maintenance

6.6 Resolution

6.7 Disaster Recovery Plan/Continuity Plan

6.8 Training management/records

6.9 Document management

6.10 Periodic review/internal audit

Chapter 7. Operations team training

7.1 Training requirements and initial operator training

7.2 Training records

Chapter 8. Regulatory inspection preparation

8.1 Regulatory inspection procedures

8.2 Regulation, guidance, and standards cross-references

Chapter 9. Qualification Report and infrastructure acceptance

9.1 Infrastructure Final Report and approvals

9.2 Follow-up item tracking

9.3 System and documentation turnover

Part 2 Procedure and protocol appendixes

Appendix A. Document master list: Roles and Responsibilities Matrix

Roles and Responsibilities Matrix approvals

Appendix B. Infrastructure identification

Infrastructure Identification Test Script

Cabling Test Script

Appendix C. Infrastructure environmental requirements

Environmental Conditions Test Script

Power Supply UPS Test Script

Physical Security Test Script

Appendix D. Infrastructure functional description

Logical Partition Installation Test Script

Logical Partition Diagnostic Function Test Script

Error Reporting Function Test Script

LTO Library Connectivity Test Script

ESS Network Connectivity Test Script

High Availability Cluster Multi-Processing Function Test Script

Network Connectivity Test Script

IBM Service Agent Test Script

Service Action Event Log Test Script

Processor De-allocation Test Script

LPAR Feature Set Test Script

Service Focal Point Test Script

Network Time Protocol Test Script

Fail-over Test Script

SANPilot Test Script

Disk Storage Array Hot-swap Test Script

Barcode Reader Test Script

LTO Auto-clean Test Script.

ESS Web Administration Test Script

SDD Redundancy Test Script

SDD Installation Test Script

Sysback/6000 Test Script

TSM Service Manager Test Script

Logical Security Test Script

Appendix E. Installation Team Training/Qualifications Matrix

Qualifications/Training Matrix

Appendix F. General regulatory and 21CFR11 training

Training course goals

Training course contents and approach

Topic 1: General quality system and regulatory training

21 CFR 11 training (electronic records and electronic signatures)

Appendix G. Good Documentation Practices

Detailed explanations of Good Documentation Practices (GDP)

Entries or signatures must always be clear and legible

Entry-makers must sign their recordings

Signatures must be authentic

Entries or signatures must be made in ink

Each original data entry or signature cannot be removed

Corrections require a replacement entry that does not obscure the original

Correction entries require a signature, date, and reason

Voided entries or documents must be identified and retained

An entry or a signature must be labeled as to what it represents

Recopied data must have its source identified, attached, or both

Date and times must be unambiguous

Blank fields must be "N/A" unless obvious

Entries are made, signed, and dated immediately, not ex post facto

Document attachments must be positively linked to their point-of-origination

Document attachments must be labeled and paginated

Work organizers and work aids

Document workflows and records retention

Appendix H. Training/qualifications record

Appendix I. Resume equivalent for training and qualifications record

Training and Qualifications Test Script

Appendix J. Signature log

Appendix K. Infrastructure installation and operating manuals.

Document and Manual Verification Test Script

Appendix L. Risk assessment and mitigation plan

Risk Assessment Document

Appendix M. Testing protocol

Purpose

Scope

Responsibilities

Prerequisites

Technical design document

Training

Infrastructure preparation

Infrastructure access authority and security

Test cases/scripts

Testing procedures

Infrastructure manuals

Acceptance criteria

Test Report

References

Appendix N. Trace Matrix

Appendix O. Test execution procedure

Roles and responsibilities

Protocol and test cases/Scripts approved

Testing assignments

Equipment, database, and dataset or datasets preparation

Instructions: Test Manager

Test assignments and log

Deviations management

Test case/Script review

Instructions: Tester

Test case/Script execution

Variable input data values

Screen prints and reports

Test discrepancies

Test review and signature

Test Assignment Log

Appendix P. Deviations procedure

Deviation request

Deviation documentation

Deviation package delivery

Retesting

Instructions: Technical Staff

Deviation investigation

Deviation resolution documentation

Retesting requirements

Deviation package

Deviation identification

Deviation logging and tracking

Deviation investigation and resolution

Deviations with change and retesting

Deviation review and closure

Non-testing deviations

Deviation Report

Deviations log

Appendix Q. Validation reports procedure

Instructions: Report Preparer

Report preparation

Documentation

Instructions: Quality Representative

Report Quality Review.

Report approval

Appendix R. Infrastructure procedures verification checklist

Procedure Verification Checklist Test Script

Appendix S. Regulation, guidance, and standards cross references

Regulations, guidance, and standards to IBM Installation Qualification requirements

Part 3 FDA 21 CFR Part 11 and guidance

Appendix T. FDA 21 CFR Part 11 Preamble

I. Background

II. Highlights of the Final Rule

III. Comments on the Proposed Rule

A. General Comments

B. Regulations Versus Guidelines

C. Flexibility and Specificity

D. Controls for Electronic Systems Compared with Paper Systems

E. FDA Certification of Electronic Signature Systems

F. Biometric Electronic Signatures

G. Personnel Integrity

H. Security of Industry Electronic Records Submitted to FDA

I. Effective Date/Grandfathering

J. Comments by Electronic Mail and Electronic Distribution of FDA Documents

K. Submissions by Facsimile (Fax)

L. Blood Bank Issues

M. Regulatory Flexibility Analysis

N. Terminology

O. General Comments Regarding Prescription Drug Marketing Act of 1987 (PDMA)

P. Comments on the Unique Nature of Passwords

IV. Scope (Sec. 11.1)

V. Implementation (Sec. 11.2)

VI. Definitions (Sec. 11.3)

VII. Electronic Records

Controls for Closed Systems (Sec. 11.10)

VIII. Electronic Records

Controls for Open Systems (Sec. 11.30)

IX. Electronic Records

Signature Manifestations (Sec. 11.50)

X. Electronic Records

Signature/Record Linking (Sec. 11.70)

XI. Electronic Signatures

General Requirements (Sec. 11.100)

XII. Electronic Signature Components and Controls (Sec. 11.200)

XIII. Electronic Signatures

Controls for Identification Codes/Passwords (Sec. 11.300)

XIV. Paperwork Reduction Act of 1995

XV. Environmental Impact

XVI. Analysis of Impacts

A. Objectives

B. Small Entities Affected.

C. Description of the Impact.

Notes:

Bibliographic Level Mode of Issuance: Monograph

Includes bibliographical references.

OCLC:

228124017