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Here is a book that one peer reviewer called "brilliant." Written by a well-know subject matter expert, this book describes the latest tools, techniques and regulatory information needed to validate enterprise systems. Subjects covered include challenges, acquisition and procurement, developing and documenting user requirements, validation planning, governance, data migration, prototyping pilots, test strategies, electronic records, customization, risk management, SOPs, validating in the cloud and much, much more.
Book written in July, 2012
Table of Contents:
Click here to download >>>Detailed Table of Contents
- The Challenge of Enterprise Systems
- Acquisition and Procurement
- Developing and Documenting User (Business) Requirements
- Validation Planning
- Governance Procedures
- Data Migration
- Prototyping and Conference Room Pilots
- Test Strategies
- Managing Configuration Settings
- Electronic Records and Signatures
- Infrastructure Qualification
- Detailed Risk Management
- SOPs and User Training
- Testing Enterprise Systems
- Validating Enterprise Applications `In the Cloud`
- Go Live!
- Post Go Live
- Retrospective Validation
- Maintaining the Validated State
Appendix A — Definitions
Appendix B — References and Bibliography
C — Validation Basics and Validation Master Plan Structure and Content
About the Author
David Stokes has more than twenty years' experience in the development, implementation and validation of computer systems and software applications in the life sciences industries. He is currently Life Sciences Industry Manager and Principal Validation Consultant for Business & Decision, where he provides high level regulatory and computer systems validation consultancy and is responsible for the development of industry leading solutions including a streamlined approach to the validation of large configurable systems.
Before joining Business & Decision he spent fifteen years in the field of process control and automation and was closely involved in the implementation and validation of manufacturing solutions. Since joining Business & Decision he has been involved with the validation of more than a dozen complex Enterprise Resource Planning systems including applications from Oracle, SAP and other ERP vendors in the pharmaceuticals, medical devices and biotechnology sectors.
Working with ERP implementation teams from within his own company and with other third party system integrators his project responsibilities include not only computer systems validation and regulatory compliance, but also project planning, project management and the development of project specific system development life cycles.