Software qualification is usually separated into two distinct activities; the structural testing and the functional testing. The structural testing includes the vendor audit, review of the code, and checks on the integrity of the code, for example, so that there is no dead code (ie, nonoperational code that may cause a “crash” or data error). The functional testing is just as the name implies, testing the functionality of the operation of each part or software function.

Basic CSV8—Black Box—Gray Box—White Box Testing

A middle approach is “gray box” testing. As the name implies this is between the full white box and black box testing programs. Some structural tests will be performed yet the emphasis is on functional testing. Most equipment that contains a PLC or other controller is usually tested using gray box or black box testing while the higher-level control systems usually undergo more white box testing and more functional testing.

Computer Life Cycle

• Concept—establishing system requirements

• Project—GxP (GMP, Part 11, etc.) assessment and release

• Operation—part of the full qualification program where a qualified state needs to be maintained

Only gold members can continue reading. Log In or Register to continue

Mar 4, 2017 | Posted by in PHARMACY | Comments Off on Considerations

Full access? Get Clinical Tree

Get Clinical Tree app for offline access
%d bloggers like this: