Non-GMP (Unregulated) Change Control

For non-impact, non-GMP, or non-manufacturing systems BSUBAS anticipates that there is no formal client Quality Unit functioning as the ultimate Change Authority.

If the client has existing Automation System Change Control procedures in place, BSUBAS coordinates these execution and documentation practices. If not the BSUBAS Change Control service will provide a generally accepted good practice change control activities which we define as:

• No execution of changes prior to the notification and official consent by the Automation System Owner and the associated Business Unit.
• No execution of changes without prior assessment of potential impact on system operations, parameters, and sequences of operations. This would include an expanded assessment to included networks and data exchange systems.
• Prior review and any possible factory, simulated or virtual testing, including the use of test scripts, of proposed changes.
• Formal procedure for proposal, assessment, definition of accompanying measures, method of implementation and change roll-back, approval and follow-up of each change.
• Full documentation of change control procedure.
• Evaluation of the success after the execution of a change.