Keeping up with the ever-evolving technology is not a cakewalk. Machine learning and automation were, in the recent past, seen as futuristic goals. Today, it is a reality. As more stakeholders continue to realize the value of the advancements, FDA hasn’t been left behind. For decades, CSV (Computer System Validation) has held the fort rigidly. However, with the growing tech needs, some revisions are needed to facilitate the inclusion of emerging trends. The process might feel overwhelming; it doesn’t, not when you can get guidance on computer software assurance from the pros.
While effective, CSV is also a barrier to adopting new tech, stressing the need to evolve to realize the value of modern advancements. That’s what CSA (computer software assurance) is targeting. CSA aims to facilitate critical thinking and a risk-based approach over rigid script testing. Evolving from CSV into CSA promises many benefits. The benefits include;
- Enhanced efficiency
- Better protection to patients
- Data integrity
- Improved products quality
- Improved software fault’s detection, to mention a few
It is exciting, but not without challenges as organizations look to switch. As you consider it, here is what you need to know about CSA to help you make an informed decision.
A lesser burden on documentation
Scripted step-by-step test procedures required under CSV adds significant documentation burden. Whether a feature or system is indirect/direct, it had to follow a detailed script. Such script, including covering low-risk systems, translates to considerable time designated to not-so-productive endeavors. Documentation burden lowers productivity while acting as a barrier to critical thinking. CSA eliminates this problem, concentrating on less burdensome documentation through unscripted testing. CSA could reduce documentation, especially paperwork, to considerable lengths, say by 80%. Unscripted testing isn’t inferior; it just focuses on the most pressing concerns.
Fewer production problems
CSV concentrates on dry-running protocols. This means lots of issues are encountered in the production process. CSA focuses on challenging the system. With room for critical thinking and a risk-based approach, the process doesn’t encounter as many issues. This reduces cycle time since from test creation, review and approval, it is about software quality. With fewer issues like script errors, the execution time is reduced since they are unscripted and more geared towards high-risk features. Fewer production hiccups, with a focus on quality, improve productivity. It is an area CSV has failed to address, requiring revision as seen in CSA.
Risk-based on impact
Among the top highlights that derail the production process is the focus on risks, regardless of their impact. CSA focuses on risks based on their impacts. This is mainly on patients’ safety and product quality. With more emphasis on quality, the process is less complicated while conforming to FDA’s regulations. There are no additional regulations included in CSA.
Switching from CSV to CSA will improve your organization’s quality and efficiency. However, the process requires adjustments. The changes, while important, can interrupt your operations. Nonetheless, with guidance on computer software assurance by the pros, you’ll enjoy a smoother transition. Evolving to the modern approach is necessary, a consideration you can address by enlisting professional services with the resources and skills to hold your hand.