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

Lab5 - Webdesign Schweiz 

You want to implement a new computer system to increase productivity and lower costs. The computer system includes hardware, software, processes, and instructions used to train your workforce. Most companies mine their IT departments and software vendors to find a project leader. What usually occurs is a series of delays, errors, and rework that result in more and more costs. What was your experience the last time you were involved in a software implementation project? Improper systems implementation causes a reduction in productivity, frustrates employees, and brings a sour mood to the corporate culture.

Most organizations have experienced staff to do some of the needed activities but rarely is there someone present that has sufficient skills and experience to lead a complete software implementation project (also known as system implementation). The main reason companies don’t have this resource is that it isn’t a full time permanent position; at least you hope it doesn’t turn out that way.

Consider these required skills:

  • Analyze system requirements: What functionality is actually needed and will be highly effective in increasing productivity?
  • Evaluating software vendors: What is the best software to buy?
  • Evaluate software development vendors: What are the best technical and long-term resources to develop custom software applications?
  • Develop contracts with external resources that are fair and cost constrained.
  • Manage IT and vendor resources for installation.
  • Facilitate user groups to work together so that new, highly effective processes are developed that will ensure increased productivity.
  • Assess risk in the new processes and identify mitigating safeguards.
  • Develop test approaches that prove system operation and system performance.
  • Write instruction and training materials that effectively educate the workforce so they are immediately productive and confident.
  • Establish a process for making system changes that ensures continuous process improvement, and supports long term growth and stability.

David Nettleton has successfully completed projects for a wide range of industries that include, electrical engineering, software development, telecommunications, nuclear power, medical devices, and pharmaceuticals.

Steve Cates has been implementing ERP systems since 1986, before it was referred to as “ERP.” His background combines experience in both finance and operations so he is able to assist in the implementation and validation of accounting software, manufacturing, and distribution modules. He combines selection and implementation project management with a background in validation and compliance.

Together, David and Steve will help you achieve your goal of a speedy, cost effective implementation of your ERP solution, insuring it is compliant, and maximizing the return on your investment.

We use a consistent time proven approach that has the following benefits:

  • Excellent Return On Investment (ROI): Increased productivity, and increased data security safeguards for intellectual property.
  • Maximizes the value of the computer system and the employees that use it.
  • Reduces labor costs by increasing employee efficiency and effectiveness.
  • Ensures projects are implemented on schedule and on budget.
  • Saves money by discovering defects early, before failures occur in production, thereby avoiding product recalls.
  • Reduces risk and legal liability.
  • Provides for continuous process improvement.
  • Minimize documentation while providing evidence of due diligence required by customers, partners, and regulatory agencies.

Schedule a consultation to discuss your needs and concerns.

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.