Installation Qualification of IBM Systems and Storage for FDA Regulated Companies.

Redbooks, IBM.
Durham : I B M, 2003.
1 online resource (460 pages)

Location Notes Your Loan Policy


United States. -- Food and Drug Administration.
Drug development -- United States -- Computer programs.
Drugs -- United States -- Testing -- Computer programs.
Electronic books.
Front cover
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
Technical design document
Infrastructure preparation
Infrastructure access authority and security
Test cases/scripts
Testing procedures
Infrastructure manuals
Acceptance criteria
Test Report
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
Roles and responsibilities
Instructions: Tester
Deviation request
Deviation documentation
Deviation package delivery
Instructions: Technical Staff
Deviation investigation
Deviation resolution documentation
Retesting requirements
Deviation package
Instructions: Test Manager
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
Roles and responsibilities
Instructions: Report Preparer
Report preparation
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.
Description based on publisher supplied metadata and other sources.
Local notes:
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2021. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
Other format:
Print version: Redbooks, IBM Installation Qualification of IBM Systems and Storage for FDA Regulated Companies