Summary: Software system ensures precise lab results in compliance with federal regulations.
As a leading company in the pharmaceutical industry, this client delivers critical therapies for life-threatening conditions.
Our client's laboratories assure the quality and viability of their products. A "low" quality product could be a deathly serum. As a result, accurate and precise analysis of laboratory results in compliance with federal regulations is critical to their business and the patient population.
Every day their laboratory analysts perform many tests and gather numerous sets of raw data. They had to manually calculate the results of their tests, which are potential sources of error and causes of low productivity. To optimize their process, our client wanted a software application that would calculate the results given the raw data.
In this situation, the solution had to meet the FDA's strict current Good Manufacturing Practices. In other words, there was zero tolerance for bugs.
The challenge was to build an application, which would serve their purpose and keep the cost of validation within budget. Because of our familiarity with the pharmaceutical industry, we understood the pitfalls of software applications used in their critical business processes. Many people have the misconception that more is better, especially when it comes to custom software, but this is the main reason for software failures during validation. Inputs and outputs need to be controlled and the number of alternate pathways need to be minimized. So, the more options you give to the user in the software applications, the more options you need to validate. Also, each additional option that is available to the user increases the possible sources for user error.
Knowing this, we developed a software application for analyzing laboratory data which was validated way before schedule and on budget. We assisted in protocol development, execution and final report generation and were readily available for questions and support through the validation process.