Two Partners. Two Practical Principles. One Powerful Approach.
The Practical Solutions Group, LLC
152 Witherspoon St.
Princeton, NJ 08542
P: 609.683.0756
F: 609.683.0758

14th Annual Validation Week

Outsourcing is a hot topic in our industry because it is a preferred, and sometimes even necessary, business model for many companies. We believe that controversies and frustration often arise from the fact that companies 1) do not know how to properly select an outsourcing provider, 2) do not have enough experience with properly formalizing ways for interactions and communications with their outsourcing providers and 3) do not understand enough about the critical components that make a relationship with an outsourcing provider work. Let’s see what can be done to capitalize on the outsourcing services, at least in the area of computer system validation.

  • Identify the key business decisions/components regarding outsourcing
  • Understand the risks and benefits to outsourcing
  • Understand the rationale behind seeking an outsource provider
  • Learn how to select an outsource provider
  • Understand how to implement and maintain an effective relationship with the outsource provider

Computer system validation has traditionally been viewed as burdensome, time consuming and expensive. Why is this? The reason is because those involved in computer systems validation more often than not do not completely understand what system validation is intended for or how to assess risks vs. benefits, or are afraid to take risks. Therefore, they have developed and implemented excessive validation strategies that result in the above-mentioned inefficiencies. It doesn’t have to be that way.

  • How to Determine the Value to Management of a Risk-Based Approach
  • Understand the primary risk areas generally regarding computer system validation
  • Learn about what management expects from a compute system validation effort
  • Understand the concept of effectiveness as it relates to computer system validation
  • Understand the concept of efficiency as it relates to computer system validation