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 Objects and Different Actions within Objects. Objects are simply the screens in the system.

The system has a set of predefined Security Actions. Actions are the specific rights granted at the Record level. Each Action corresponds to a particular action in an object (screen) and a button or check box on that screen. The role with permissions for that action will be able to insert or update action and confirm action in that object by entering their digital signature.

InstantGMP™ MD is a medical device manufacturing software system that was designed using Business Requirements Specifications. The software is a full-scope integrated manufacturing system that streams the entire manufacturing process including inventory control, material management, specification control, and electronic batch records. Overall, the software simplifies documentation and approval procedures, increases production efficiency, and provides a centralized system for manufacturing documentation. Furthermore, quality assurance procedures were written simultaneously during InstantGMP™ MD development in order to maximize quality, reduce errors, and ensure GMP compliance.

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