This short video explains, in simple terminology,
what Computer System Validation is,
and how it saves your company money!

Lab5 - Webdesign Schweiz 

Steve Cates has implemented more than two dozen ERP systems that include FDA-compliant validation. His background combines experience in both finance and operations so he is able to assist in the implementation and validation of accounting (Sarbanes-Oxley), manufacturing, and distribution modules.  

What can Steve do for you today?

I have been managing ERP selections, and implementations for in process and discrete manufacturing firms for over twenty years.  That allows me to readily understand your business requirements.  Most of the core business processes for companies are very similar if not the same.  With my background, I can quickly identify the processes that make your company unique and use them to review and select the best software to match your specific needs.  These are the processes that give your firm a competitive advantage in the marketplace and you need to be sure that any solution you choose addresses those needs.

How Steve Cates and David Nettleton work together to help companies meet their objectives?

With our combined experience in computer system validation, David and I can audit the software firms for compliance and begin the process of creating the requirements documents that will be used during validation while we are still in the selection phase. 

This cuts implementation time and allows you to leverage the selection process and selection budget with the validation process. Then we will develop the process maps that can be used during selection and implementation to ensure that all of the requirements are addressed. 

With David as the trainer and reviewer and my assistance in developing the documents, we can work with the selected vendor to prepare the specifications documents during the training cycle.  This shortens the validation time and saves you time and money.

We all know that no software will fit every process you do.  Having completed over three dozen ERP implementations I have encountered multiple requirements that call for custom or third party solutions, anything from WMS systems to automated weighing processes.  This experience allows me to assist you and the vendor in understanding the issues that the software does not address.  There is a solution to every issue. Sometimes it is hardware, sometimes it is software, and sometimes it is procedural.  It is important to identify the requirements of these issues accurately so that the solution will work effectively and can be validated when implemented.

During validation, David and I will work with you to develop your SOPs, work instructions, and training documents along with the validation documents.  Once the software is validated, it is critical that the software stay in a validated state.  We will create the SOPs and software change request documents to implement software change control.  We have the background necessary to streamline your transition from the validation effort to maintaining the system.

With our background in systems selection, implementation, validation, and 21 CFR Part 11 compliance, we will achieve your goal of a speedy, cost effective implementation of your validated ERP solution.

David's Books

One of the nation's foremost experts on CSV for 21 CFR Part 11, David Nettleton has written four books with Janet Gough:

Risk Based Software Validation
Risk Based Software Validation - Ten easy Steps

Electronic Record Keeping
Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164

Managing the Documentation Maze
Managing the Documentation Maze
Read a Review

Commercial Off the Shelf COTS Software Validation
Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance

See the Books page for more information and to order.