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Library | Item Barcode | Call Number | Material Type | Item Category 1 | Status |
|---|---|---|---|---|---|
Searching... | 30000010201818 | RS192 S44 2008 | Open Access Book | Book | Searching... |
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Summary
Summary
Standards, technologies, and requirements for computer validation have changed dramatically in recent years, and so have the interpretation of the standards and the understanding of the processes involved. 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. The book 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.
Author Notes
Siri Segalstad has worked with quality and validation of IT systems since 1988 in and with the pharmaceutical industry. She set-up her own consulting company, Segalstad Consulting AS, covering these issues in 1995, and has hands-on experience with major companies in the US and in 10 countries in Europe, including Alpharma, AstraZeneca, Bayer, GE Health, Lundbeck, Nycomed, Pharmacia & Upjohn, Statoil, and various accredited laboratories. She has published more than 20 papers and given presentations and taught classes on validation from Hong Kong, Singapore, Taiwan, and Dubai in the East to California in the West.
She has been on the board of the GAMP (Good Automated Manufacturing Practice) Nordic Steering Committee since its inauguration in 2001, and has participated in preparing standards in ASTM and GAMP.
Table of Contents
| Preface and Acknowledgements |
| 1 Quality Standards |
| 1.1 What Quality is |
| 1.2 Mandatory and Voluntary Standards |
| 1.3 Pharmaceutical Industry Regulations |
| 1.4 US GXP Regulations.1.5 European GXP Regulations |
| 1.6 Other GXP Regulations |
| 1.7 Good Manufacturing Practice û GMP |
| 1.8 Good Laboratory Practice û GLP |
| 1.9 Good Clinical Practice û GCP |
| 1.10 Medical Device Standards |
| 1.11 It Systems in The GXP And Medical Device Regulations |
| 1.12 GAMP |
| 1.13 Mandatory Quality Standards in Other Industries |
| 1.14 Legal Issues |
| 1.15 ISO |
| 1.16 ASTM |
| 1.17 IEEE |
| 1.18 TASKS |
| 2 |
| 2.1 Introduction |
| 2.2 US Requirements |
| 2.3 EU Requirements |
| 2.4 21 CFR Part 11 |
| 2.5 THE "Part 11 Project" |
| 2.6 EU GMP Annex 11 |
| 2.7 PIC Document PI 011 Recommendation on Computerised Systems In Regulated "GXP" Environments |
| 2.8 GAMP |
| 2.9 ISO 9000-Series |
| 2.10 Comparison Between the Standards |
| 2.11 Conclusion |
| 2.12 Tasks |
| 3 IT Security |
| 3.1 Introduction |
| 3.2 Continuous Connections - Wireless Networks |
| 3.3 Threats |
| 3.4 Security Policy |
| 3.5 Tasks |
| 4 Quality Management Systems |
| 4.1 Introduction to QMS |
| 4.2 Definitions |
| 4.3 Principles for Quality Management |
| 4.4 Quality Management System Levels |
| 4.5 Creating a QMS |
| 4.6 Roles and Responsibilities |
| 4.7 Work Processes |
| 4.8 Controlled Documents |
| 4.9 Quality PolicyùQP |
| 4.10 Quality ManualùQM |
| 4.11 Standard Operating Procedures |
| 4.12 The Art of Writing an SOP |
| 4.13 Tasks |
| 5 IT Integrated In the QMS in a User Organization |
| 5.1 Introduction |
| 5.2 How to Integrate the IT Systems in the QMS |
| 5.3 Generic Standard Operating Procedures (SOPS) |
| 5.4 Procedures for Each System |
| 5.5 Tasks |
| 6 IT Integrated in the Supplier's QMS |
| 6.1 Introduction |
| 6.2 Which Standards to Use? |
| 6.3 Quality Management System |
| 6.4 System Development Models |
| 6.5 Documents for the Software Development |
| 6.6 Customer-Supplier Relationship |
| 6.7 Tasks |
| 7 Organization for an IT System |
| 7.1 Introduction |
| 7.2 Roles and Responsibilities for a Live System |
| 7.3 Groups in the IT System Organization |
| 7.4 Roles and Responsibilities for an IT Validation Project |
| 7.5 Outsourcing.1.1 Service Level Agreement for Outsourcing |
| 7.6 Consultants |
| 8 The Legal Implications of an IT System |
| 8.1 Introduction |
| 8.2 Pharmaceutical Regulations |
| 8.3 Financial Systems |
| 8.4 Patent Systems |
| 8.5 Human Resource (HR) Systems |
| 8.6 Healthcare Systems |
| 8.7 Systems for Legal Information |
| 9 Advanced Quality Management Systems |
| 9.1 Introduction |
| 9.2 The Live QMS is a Good QMS |
| 9.3 Changes |
| 9.4 How to Keep the QMS Updated |
| 9.5 Training and Understanding |
| 9.6 How to Use A QMS Effectively As A Tool In The Organization - Not As a Straightjacket |
| 9.7 Tasks |
| 10 Audits |
| 10.1 Introduction |
| 10.2 ISO 9000 Series |
| 10.3 Tickit |
