International IT regulations & compliance: quality standards in the pharmaceutical & regulated industries
Auteur : SEGALSTAD Siri H.
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 GMP.
1.8 Good Laboratory Practice GLP.
1.9 Good Clinical Practice 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. Regulatory Requirements for IT Systems.
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 QMS.
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 Policy QP.
4.10 Quality Manual QM.
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 Suppliers 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. 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.
10.4 Why Audit?
10.5 Audit In A Risk Based Environment.
10.6 Audit Scope.
10.7 Supplier Audit...
Date de parution : 01-2009
Ouvrage de 360 p.
17x24 cm
