Quality Assurance -What are the benefits of Software Quality Assurance ?
Article Context:
Introduction
Amid 2020, quality assurance leaders in the pharmaceutical, medical device, and other FDA-regulated industries highlighted compliance and production as part of their quality goals. Maintaining consistent compliance has remained part of the top three challenges the industry has been experiencing. How can firms in the life science industry overcome these challenges? Software Quality Assurance is the key industry trend and has many benefits in preventing mistakes to ensure compliance and patient safety.
To summarize, software validation has been a requirement by the FDA since 1997. Software Quality Assurance (SQA) is the set of activities that ensure processes, procedures as well as standards are suitable for the project and implemented correctly
Furthermore, pharmaceutical and medical device companies may be one of the same.
Today, many companies in the industry are still being audited and fined at high costs for similar but different compliant regulated issues.
While it is no surprise compliance tops the list of quality system challenges, resourcing as a close second appears to be an emerging point of focus. Especially given how little comparative attention it garners among industry thought leaders
Below are the top five individually compliant issues for Pharma and Med-Device reported in the last fiscal year of 2020.
Pharma
- Responsibilities of the quality unit (21 CFR (Code of Federal Regulations) 211.22)
- Written procedures; deviations (21 CFR 211.100)
- Testing and release for distribution (21 CFR 21.165)
- Production record review (21 CFR 211.192)
- Testing and approval or rejection of components, drugs product containers, and closures (21 CFR 211.165) & Stability testing (21 CFR 211.166)
Med-Device
- CAPA (21 CFR 820.100)
- Design controls (21 CFR 820.30)
- Purchasing controls (21 CFR 820.50)
- Process validation (21 CFR 820.75)
- Complaint files (21 CFR 820.198)
In other words, what happens when you neglect Quality Assurance? This is where patient safety begins. For example, the National Cancer Institute went through one of the worst software disasters when a bug destroyed their radiology equipment. Due to this, their devices administered radiation doses 100 times higher than required.
Quality leaders must invest in proper validation to implement best practices to ensure patient safety. Testing efforts should start as early as possible. Speaking, the sooner we find a bug, the cheaper it will be to fix it
Finally, let’s discuss the benefits of Software Quality Assurance. Overall, the first and crucial benefit to Quality Assurance is saving your firm time. According to CrossTalk’s analysis of “The Journal of Defense Software Engineering,” differences in the time to fix errors or problems depend on the phase of the software development cycle. According to the analysis, it can take up to 150 times longer to repair an error that occurred in production than to repair the same error at the requirements design stage.
Quality Assurance will provide efficiency to your firm’s validation processes. Another benefit includes your firm’s potential to save money. How can this be? The concept is simple when you are wasting money. The result will entail losing and scaring away project opportunities. Also, it tarnishes your firm’s credibility and reputation.
As a result of overall efficiency, your firm will benefit from testing your products with an elevated level of confidence in which Quality Assurance delivers. Only enough tests are carried out to ensure our software and its compliance with the requirements. Creating software creates value for users, and it is through inadequate quality we do not deliver value.
With elevated confidence, staff will feel valued because they meet high standards for testing.
On balance with efficiency, it also delivers reliability. Implementing Quality Assurance means the prevention of breakdowns. When a firm performs tests, your QA team will help reduce costs on maintenance for any future applications. System failure is not an unusual event. But during quality testing, you need to examine the system’s ability to withstand component failure. The system should be able to get back into the entire operation even after a possible failure in the software.
Lastly, Quality Assurance will boost your safety. Such as preventing data leaks and amping your firm’s cybersecurity. Informational Technology and Quality are entirely different. However, there will always be a commonality between the two departments. Quality Assurance is beneficial for all areas and departments in the life science industry. When you implement the best practices of Quality Assurance, your firm will benefit from Quality Assurance’s ability in functionality, reliability, usability, efficiency, maintainability, and portability.
Along with implementing software, Compliance Group is here to help guide you through enhancing your quality assurance needs or training. One of our CSA industry experts will gladly discuss your current state and recommendations. Call us at (847) 327-3167 ext. 406 or email: sales@complianceg.com
FAQ's
What is meant by software quality assurance?
Software Quality Assurance is a process that ensures that the quality of the software that is being used is maintained. This is done by carrying out various activities that are designed to prevent issues before they can happen.
What is software quality assurance with example?
Alpha testing is a type of validation test that’s carried out in the software quality assurance process. It involves testing the software before it’s released to the public.
How do you write a software quality assurance plan?
A good quality assurance plan is the first step in developing a project’s quality assurance program. It involves planning how the various activities will be carried out throughout the project.
What is quality assurance in medical device?
Quality assurance is a process that’s carried out throughout the manufacturing process of medical devices. It prevents issues related to the way the devices are made.
Why is quality assurance important in healthcare?
For instance, when a bug destroyed the equipment of the National Cancer Institute, the devices were able to deliver higher radiation doses than intended.
What are the methods of Quality Assurance?
Various factors such as cost-benefit analysis, operations analysis, and quality specifications are also taken into account before implementing a quality assurance program.