Trace Matrix Gap

Inevitably, we all run into a documentation gap.  Restarting the workflows to initiate the change, approve, test, and review can add weeks to go back to design documents. Alternatively, it may be possible to just accept the gap and note it will be resolved in a follow up project.

It really depends on the size of the project, complexity, and sophistication of your vendors. Contact us to help navigate through tough GMP validation situations such as these.