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[…]

Detailed Design Specification – Manufacturing Software Validation

The Detailed Design Specification (DDS) describes how the hardware and software functionality identified in the Functional Specification will be developed and implemented. The Hardware DDS is a description of the hardware on which the software resides and how it is to be connected to any existing system or equipment. Where possible, hardware used should be[…]