Are you Prepared for Validation? - Sponsored Whitepaper

For industries that operate in regulated environments, validation of processes and systems is an important and required part of business. The goal of the validation process is to provide a high degree of confidence in a process or system by demonstrating consistent and repeatable operational results through documented evidence. The exact requirements of a compliant validation will be detailed by the appropriate regulatory agency that oversees your business sector. If your business uses Good Practices (GxP) and is in the food, pharmaceutical products, or medical devices business sectors, then you are likely required to comply with a regulatory agency. Failure to comply with regulations could lead to fines, suspension of business, or even loss of your business. This article will provide an overview of a validation for a computer software system to be compliant with Food and Drug Administration (FDA) regulations.

Computer software can be employed within an organization to gain efficiency or perform functions that are specialized. Software can consolidate data and make data analysis more effective or flexible. For all of the positive things software can provide, it is not a magic bullet that will solve problems without understanding the requirements for obtaining the desired results. Understanding the scope and requirements of processes that the software will be employed is the first step in executing a successful validation.

Gathering requirements is a critical step for implementation of software. Documentation of features and functions will provide the validation process with the information needed to develop the appropriate test scripts that will demonstrate all requirements are satisfied.