International IT Regulations and Compliance brings together current thinking on the implementation of standards and regulations in relation to IT for a wide variety of industries.
International IT Regulations and Compliance provides professionals in pharmaceutical and semiconductor industries with an updated overview of requirements for handling IT systems according to various Quality Standards and how to translate these requirements in the regulations.
Contents
1. Quality Standards
- What Quality is
- Mandatory and Voluntary Standards
- Pharmaceutical Industry Regulations
- US GXP Regulations
- European GXP Regulations
- Other GXP Regulations
- Good Manufacturing Practice - GMP
- Good Laboratory Practice - GLP
- Good Clinical Practice - GCP
- Medical Device Standards
- It Systems in The GXP And Medical Device Regulations
- GAMP
- Mandatory Quality Standards in Other Industries
- Legal Issues
- ISO
- ASTM
- IEEE
2. Regulatory Requirements for IT Systems
- US Requirements
- EU Requirements
- 21 CFR Part 11
- The "Part 11 Project"
- EU GMP Annex 11
- PIC Document PI 011 Recommendation on Computerised Systems In Regulated "GXP" Environments
- GAMP
- ISO 9000-Series
- Comparison Between the Standards
3. IT Security
- Continuous Connections - Wireless Networks
- Threats
- Security Policy
4. Quality Management Systems
- Introduction to QMS
- Definitions
- Principles for Quality Management
- Quality Management System Levels
- Creating a QMS
- Roles and Responsibilities
- Work Processes
- Controlled Documents
- Quality Policy--QP
- Quality Manual--QM
- Standard Operating Procedures
- The Art of Writing an SOP
5. IT Integrated In the QMS in a User Organization
- How to Integrate the IT Systems in the QMS
- Generic Standard Operating Procedures (SOPS)
- Procedures for Each System
6. IT Integrated in the Supplier’s QMS
- Which Standards to Use
- Quality Management System
- System Development Models
- Documents for the Software Development
- Customer-Supplier Relationship
7. Organization for an IT System
- Roles and Responsibilities for a Live System
- Groups in the IT System Organization
- Roles and Responsibilities for an IT Validation Project
- Outsourcing
- Consultants
8. The Legal Implications of an IT System
- Pharmaceutical Regulations
- Financial Systems
- Patent Systems
- Human Resource (HR) Systems
- Healthcare Systems
- Systems for Legal Information
9. Advanced Quality Management Systems
- The Live QMS is a Good QMS
- Changes
- How to Keep the QMS Updated
- Training and Understanding
- How to Use A QMS Effectively As A Tool In The Organization - Not As a Straightjacket
10. Audits
- ISO 9000 Series
- Tickit
- Why Audit
- Audit In A Risk-Based Environment
- Audit Scope
- Supplier Audit Preparations
- During the Audit
- What To Look For
- Other Issues
- Findings/Discrepancies
- Closing Meeting/Wash-Up Meeting
- Audit Report
- Conducting an Audit from the Receiving End Of The Table
11. Validation of IT Systems
- External Requirements for Validation
- Internal Requirements for Validation
- Validation Cost
- Inspectors
- Validation Scope Is Changing
- Computer Validation Project
- Which Hardware and Software Shall Be Validated
- Network
- Software
- Risks and System Categories
- Qualifications
- DQ - Development Qualification
- IQ - Installation Qualification
- OQ - Operation Qualification
- PQ - Performance / Process Qualification
- Validation Master Plan VMP
- Validation Plan VP
- Validation Report
12. Risk Assessment and Risk Management
13. Development Qualification
14. Installation Qualification
15. Operational Qualification
16. Process/Performance Qualification
17. Laboratory Instrument Systems
18. Laboratory Information Management Systems
19. Building Management System (BMS) and Heating, Ventilation, Air Conditioning
Index
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