The Food and Drug Administration has introduced new guidance for ensuring the consumers’ safety, security, and efficacy are met. This new guidance, called Computer software assurance, serves as a new way of looking at computer system validation. It has achieved this by emphasizing the application of consideration of risks involved and critical thinking on focusing on what matters on data integrity, products quality, and patients safety. Notably, the computer assurance approach only applies to non-product systems. This article will look at the various benefits of the computer assurance approach.
Why Computer Software Assurance Is More Efficient Than CSV
The speed and efficiency of CSV have emerged for years. It was considered a significant factor before the introduction of CSA, hence the need to shift from CSV to CSA. Research shows that computer system validation has started becoming a burden for life science organizations over the years. This is because the users spent less effort and time concentrating on quality and instead spent most time fulfilling the necessary extensive documentation.
Also, most companies saw the need to shift to Computer Software Assurance due to the risks and frustrations that came with CSV. This is because, for years, nothing changed on the CSV, but with the CSA, it came to bridge the gap between the technology and regulation. So, the company owners would now concentrate on areas such as patient safety, product quality, and speed to the market instead of taking time with the documentation.
What Does Computer Software Assurance Focus On?
Computer software assurance came to bridge the gap between technology and required regulation. So, it aims at reducing unnecessary documentation by mitigating any risks involved with the validation process and assuring the software is fit to serve the purpose it was intended for. The Computer Software Assurance approach will focus on the below areas:
- Assurance that demonstrates if the functionality and features are working as desired.
- Critical thinking that highlights the risk definition of each software feature
- Test activities that define and leverage the different test methods, such as unscripted and scripted testing.
More about Computer Software Assurance FDA Compliance
The FDA’s Center for Devices and Radiological Health has an intention to harmonize with international standards. So, they plan to release the new draft guidance, which is the computer software assurance to replace the traditional Computer System Validation. The new system aligns with the current system quality regulation that focuses on quality rather than compliance. Or better still, Computer software assurance bridges the gap between compliance and quality by encouraging the use of new technologies and automation. However, you need the help of an expert to help you modernize the company’s system to a more streamlined approach.
How to Get the Company Staff Ready for the CSV-CSA Shift
The Food and Drug Authority encourages organizations to get ready for the Computer Software Assurance shift from the traditional Computer System Validation. This is because they emphasize the safety of the consumer, product quality, and the speed of the market. The most effective way to shift from CSV to CSA is through hiring experienced and highly knowledgeable professionals to help you with the process. The experts will help you prepare the staff by educating and training them on the computer software assurance approach and also providing them with proactive approaches.
The Benefits of the Computer Software Assurance Approach
One of the most significant benefits of hiring an expert to update the company’s system is that they offer CSA education and training for the company’s team. This means they will teach the staff how to apply critical thinking and principles to the process. Also, they help assess the Computer System validation to recommend the best one based on the company’s testing, documentation, and automation. To remedy the several barriers that CSV provided, FDA is introducing computer software assurance which has the following benefits over the computer system validation. Below are some of the advantages of shifting from CSV to CSA.
- Improved efficiency and quality.
- Enhance the capability of delivering value faster.
- Decrease in test script problems up to 90 percent.
- The maximized use of expert resources and Computer System Validation.
- To utilize vendor assurance activities.
- The beneficial testing overhead is significant reduction.