B&D Life Sciences

B&D Life Sciences 

Successfully Validating ERP Systems

Business & Decision's consultants contribute to many journals and magazines and have published a number of industry books.

Published by the Parenteral Drug Association in 2006, Successfully Validating ERP Systems (and other large, configurable applications) is considered to be the definitive source of practical guidance when applying risk-based principles to the validation of large, complex applications such as Enterprise Resource Planning (ERP) and other large configurable applications (Clinical, LIMS, MES, CRM etc).

Successfully Validating ERP Systems Book Cover

Explaining the underlying rationale for many common regulatory expectations Successfully Validating ERP Systems introduced many good practices since embodied in version 5 of the GAMP Guide.  The 270 page book provides practical guidance on why many large projects fail to cost effectively validate their applications and why it is often so difficult to maintain the validated state.

Written in 19 chapters, the book takes a journey through the system life cycle and is an invaluable aid to anyone planning on implementing or involved in supporting a large configurable application.

1 Introduction
2 Acquisition and Procurement
3 Developing and Documenting User (Business) Requirements
4 Validation Planning
5 Governance Procedures
6 Conference Room Pilots
7 Test Strategies
8 Managing Configuration Settings
9 Electronic Records and Signatures
10 Customizations
11 Data Migration
12 Hardware and Infrastructure Qualification
13 Detailed Risk Management
14 SOPs and User Training
15 Testing ERP Systems
16 Go Live!
17 Performance Qualification (Post Go Live)
18 Maintaining the Validated State
19 Conclusions

Win A Copy

You can win your own copy of Successfully Validating ERP Systems - the author is donating one copy every quarter to the person with the best reason for owning a copy. All you have to do is complete the form below and hope that you're a winner. Please note the rules at the bottom of the page.

Succesfully Validating ERP Systems - Entry Form

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Can't Wait?

If you can't wait to win a copy (or are plain unlucky!) you can order a copy, plus many, many other useful titles at the on-line PDA BookStore.

Title: Successfully Validating ERP Systems (and other large, configurable applications).
Author: David Stokes.
Date of Publication: April 2006.
Item Number: 17245.
ISBN Number: 1-930114-91-5.

Rules

1. One copy of Successfully Validating ERP Systems (and other large configurable applications) will be given away each quarter, with winners selected at the end of March, June, September and December of each year, from all entries submitted in the previous quarter.

2. No entries will be carried forward from one quarter to any subsequent quarter.

3. The winner will be entrant who, in the sole opinion of the author, provides the best reason for winning a copy.

4. Reasons provided should be limited to 500 characters or less

5. Entrants should be eligible for and agree to their details being added to Business & Decision's Life Sciences subscription service, with all subscription options being enabled (options may subsequently be changed at any time - see Subscription Notice)

6. Details of previous winners will be available upon request. No other correspondence will be entered into with respect to the competition

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