key point:
1. Quickly meet standards such as IEC 62304 and FDA 21 CFR Part 11
2. New support for FDA software verification standard principles
3. Support multi-site distributed, remote, or outsourced teams
4. On-demand reporting and traceability indicators are fully transparent
Typically, achieving compliance with IEC 62304 , FDA 21 CFR Part 11 , and the general principles of US FDA software validation requires tidying up mountains of documentation and purchasing expensive professional solutions. Now, TechExcel 's DevSuite system provides a A simple solution to manage the entire life cycle of your medical device software development, freeing you from the tedious and expensive before.
With the DevSuite solution, you get: 1. Full traceability of all items throughout the software application lifecycle and a security audit trail. 2. Various industry mature process templates
3. Rich reports to help you meet any audit needs
IEC 62304 Standard
IEC 62304 is an international standard for software life cycle management of medical devices, which specifies the requirements for the development life cycle of medical device software.
The IEC 62304 standard specifies several considerations for the use of software, in particular the lineage and provenance of the software. The standard establishes a risk-based decision-making model and defines a set of test requirements to ensure why such software should be used.
The TechExcel DevSuite solution helps you achieve IEC 62304 compliant annotation with a complete track record and audit trail. DevSuite can help you reduce the costs involved in complying with IEC 62304 regulations, while increasing end-user acceptance and productivity through seamless integration with industry-proven solutions.
FDA CFR Part 11 Standard Under this standard, FDA considers electronic records, electronic signatures, and hand signatures on electronic records to be trustworthy, reliable and generally equivalent to paper records and handwritten signatures on paper. Only by complying with this standard, the products produced by its manufacturers can be normally sold to foreign markets, and the data retained in compliance with this standard can be used as an effective data source for passing inspection or future traceability. Now many large-scale automation control systems already comply with this standard. This regulation ensures the validity and reliability of electronic data. TechExcel 's DevSuite makes it easy to comply with FDA CFR Part 11 standards with its built-in authentication capabilities and electronic signature compliance . So, instead of wasting your time on third-party add-ons, they cause far more trouble than they are worth, you need functionality that integrates completely seamlessly with your workflow.
FDA General Principles of Software Validation The General Principles of Software Validation recommends a comprehensive software development life cycle ( SDLC ) that can integrate risk management strategies with the principles of software validation. The FDA Software Validation Principles apply to software for medical devices or for the design, development, and manufacture of medical devices. The types of medical devices are divided into Class II and Class III , as well as some design control devices for Class I devices. These types of software must be verified by the FDA : 1. The software is used as a component, part or accessory of the medical device ; 2. The software itself It is a medical device (such as blood establishment software) 3. Mobile equipment used in the production of software (for example, production equipment in programmable logic controllers) ; 4. The software used in the implementation of the quality system of the equipment manufacturer (eg , software that records and maintains the history of the device). The TechExcel DevSuite solution accelerates FDA validation by helping companies clearly define, document, verify and validate development activities and outcomes. Of course, that's not enough, FDA
The software verification standard stipulates a "most reasonable method", which often gives a company "too much" freedom, "free" to make them "shoot themselves in the foot". TechExcel DevSuite can help you avoid these problems with predefined templates that have been proven in practice to help customers achieve success, which means that you are now building your own projects on the success and experience of others. Seamless Integration Full Traceability and Methodology Support DevSuite gives you fully integrated quality management, development and defect tracking. The most important thing here is that this integration is suitable for any development mode, such as agile, waterfall or some hybrid method. Using a fully integrated solution enables medical development teams to link all relevant items. As a result, product managers, designers, developers, and testers know exactly what the product / feature is, and instantly know that any changes, even bugs, can be linked to the original design document. This means that if a design change is required to fix a defect, then this change will be made immediately aware of all relevant items (eg testers will immediately notice that there is a change and need to retest the updated test case).
On-Demand Reporting and Visibility
DevSuite provides real-time planning dashboards and reports so you always know the status of your medical development projects. The Planning View dashboard enables all participating planners to view the status of their projects, teams, and real-time environments. DevSuite can also view dynamic reports on the client side, or send the latest data via email to relevant personnel. Achieving Repeatable Quality Standards In order to build a trackable success, you must have a repeatable process that can continuously analyze and improve, step by step toward success. TechExcel DevSuite provides a powerful workflow engine, automation of events and notifications, standardized testing, and traceability reporting. Using DevSuite , your medical development team can look back at a release and see what was done and what wasn't. This provides a mechanism that facilitates improvement of deficiencies.
Suitable for remote and outsourced teams
DevSuite can provide real-time data, it is an ideal solution for remote or outsourced testing teams, the team no longer needs to wait for the results of the remote team , it can now be directly in DevSuite Check their progress. DevSuite also has built-in security controls that allow you to limit what data is available to your outsourced teams and contractors, allowing them to work alongside your core team. Finally, the multi-site capability provides a speed that all distributed teams have a local (LAN) location. Grid-based test verification point data grids are designed for medical development. By using data grids, testers can conduct tests in formats commonly used by medical development teams, and test planners can easily design new test points. Just by plugging in new variables like blood type, gender or other common medical test points. The verification point data grid even supports a checkbox interface, making the execution of tests easier than ever.