Unlike the traditional computer system validation, Computer software Assurance is more efficient and has improved quality. However, it would help to have an expert assist in the transition from the old system to the new CSA. This is because the experts ensure that the systems are compliant with the approach, methodology, and end-user training. Also, the professionals will ensure that the test automation capabilities and validation practices significantly decrease the validation and implementation time.
How Can The Experts Help With The Transition?
With their experience and expertise in verification, qualifying, and validating the equipment, myriad systems, and processes, the highly experienced professionals will ensure that they update the existing system to the required one. They could also install a new one that will achieve the safety and security of the consumers and improve the product quality.
Also, since each company has its unique needs and specifications, they tailor its services to fit the needs of each organization. Further, the experts have handled complex systems before, so they know the regulations and rules necessary in the validation process. The company will also benefit from their expertise through the technology strategy that will chart a path of success for their company. Better still, the experts also educate and train the employees to apply critical thinking to validate the process.
What Are The Computer Software Assurance Highlights?
The FDA emphasizes the shift from computer system validation to computer software assurance to improve product quality, patient safety and bridge the gap between compliance and quality. Some of the computer software assurance highlights include:
- Approaches and principles required to regulate all applicable organizations.
- Guidance on the Food and Drug Authority’s A list.
- A non-product quality computer system software.
Why Is FDA Focused On Introducing Computer Software Assurance?
One of the most significant factors that have influenced the FDA in introducing Computer Software Assurance is bridging the gap between technology, compliance, and quality. As part of their considerable case for quality control, the Food and Drug Authority found barriers within the computer System Validation hence the need for the shift from CSV to CSA. Some of these CSV barriers include:
- Too much emphasis on documentation for the auditor instead of focusing on the quality.
- Lack of clarity on where to focus the testing and how much testing is required.
- Confusing, complex, and hard to use risk-based approaches.
- To enhance the quality, safety, and reduce patient risk through the use of automation, data solutions, and information technology.
Ways in Which FDA Guides the Computer Software Assurance
The FDA has participated in various pilot programs as part of their case for a quality program. They aim to improve the efficiency and quality of the systems in companies to ensure they maintain consumers’ safety and security. Below are some of the FDA’s methods to guide the computer software assurance approach.
- By defining direct and indirect systems.
- Through identification of acceptable approaches to direct and indirect system validation.
- Training and educating inspectors to focus their review on the chosen methodology’s critical thinking and higher risk activity.
- By emphasizing a risk-based approach to spending more time improving the methodology that fits the system using critical thinking.
- By focusing on testing the functionality, high-risk systems take less time documenting.
What Are The Benefits Of CSA To The Company?
Apart from improving the quality and efficiency of the systems, professional experts can help the company in various ways to shift from Computer System Validation to Computer Software Assurance. Here are some benefits of hiring experts to help you with the validation process.
CSA Training and Education
The experts will mentor and teach the company’s team how to apply critical thinking and the CSA principles in the process. Also, they offer virtual onsite programs to increase the awareness and knowledge of the benefits of the CSA principles.
The experts will assess the existing CSV system to recommend the best fit that will cater to the company’s needs based on the quality of testing, automation, performance, and documentation. Also, they will help build a practical CSA road map that matches the company’s priorities.
CSA methodology and development
The experts will also help to transform the existing CSV into a CSA approach that implements faster improvements to the company.