FDA Regulations Timeline

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 for them to be officially issued and companies were given time to comply. This story[…]

Manufacturing Software Validation – Design and Coding Standards

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 development phase, and especially when the program needs maintenance and changes. Sometimes programmers cannot easily[…]

User Requirements Specification – Manufacturing Software Validation

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 purpose of the URS is to define the company’s interpretation of the projected users’ solution[…]

Manufacturing Software Validation – Requirements Traceability Matrix

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 that system validation addresses all requirements, specifications and functions addressed during the test phase of[…]

Risk Management – Manufacturing Software Validation

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 understanding and potential impact on patient safety, product quality, and data integrity. Controls are measures[…]

Manufacturing Software Validation – Security Scheme

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 and access. Roles are permission sets granted to users. Roles restrict the user’s access to[…]

Business Requirements Specification – Manufacturing Software Validation

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 the BRS should be from the business perspective, not on the specifics of implementing the[…]

Software Development Life Cycle Policy – Manufacturing Software Validation

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 through software can be consistently fulfilled.”  The the software development life cycle process ensures that[…]

Quality System Requirement – Manufacturing Software Validation

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 invest hundreds of thousands to millions of dollars to install a customized manufacturing software solution[…]