While there are many concerns in the vape community about upcoming FDA regulations, they may not take effect as quickly as some may think. When the first regulations for the pharmaceutical industry were drafted in 70's, it took 20 years…
While every computer programming language has specific rules and syntax, there are usually several valid ways to achieve the same result, especially with manufacturing software. Differences in programming styles can have a substantial negative impact on a project during the…
A User Requirements Specification (URS) document may be created for all new or replacement computerized systems as defined in the Software Development Life Cycle document and may also provide the basis for the system design and Process Flow Diagrams. The…
The Traceability Matrix defines the relationship between the Requirements / Specification Documents, Design Documentation and Test Scripts as defined in the Testing Protocols for the InstantGMP™ MD medical device manufacturing software. The Traceability Matrix provides a method to trace and ensure…
Quality risk management is a systematic process for the assessment, control, communication, and review of risks. It is an iterative process used throughout the entire computerized system life cycle from concept to retirement. Risk Management is based on clear process…
In manufacturing software validation, a security scheme is used to establish a permission set for each user role. This prevents users from accessing screens or functions that are outside their responsibility or authority. Security is managed through roles, objects, actions…
The Business Requirements Specification (BRS) document defines what the system should be designed to do. The system functionality should be designed looking from different perspectives such as from the information flow, system environments and business processes perspectives. The focus of…
Looking at the life cycle policy for software development, the FDA considers software validation to be “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented…
Small enterprises that manufacture medical devices are held to the same Quality System Requirement (QSR) standards that apply to all medical devices, but often small manufacturers cannot afford the commitment and budget needed to become more efficient. Large manufactures will…