Validating Enterprise Systems: A Practical Guide

Feb 2015
PDA Item Number
Hardcover: 17303 | Digital: 18000
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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

Table of Contents:

Click here to download >>>Detailed Table of Contents

  1. Introduction
  2. The Challenge of Enterprise Systems
  3. Acquisition and Procurement
  4. Developing and Documenting User (Business) Requirements
  5. Validation Planning
  6. Governance Procedures
  7. Data Migration
  8. Prototyping and Conference Room Pilots
  9. Test Strategies
  10. Managing Configuration Settings
  11. Electronic Records and Signatures
  12. Customizations
  13. Infrastructure Qualification
  14. Detailed Risk Management
  15. SOPs and User Training
  16. Testing Enterprise Systems
  17. Validating Enterprise Applications `In the Cloud`
  18. Go Live!
  19. Post Go Live
  20. Retrospective Validation
  21. Maintaining the Validated State
  22. Conclusions

Appendix A — Definitions
Appendix B — References and Bibliography
Appendix C — Validation Basics and Validation Master Plan Structure and Content

About the Authors

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.