In Part I, “Savvy Compliance Strategy Can Improve GMP,” we took a high-level look at a process for automating regulatory compliance management. The closed-loop process starts with documenting your processes, followed by monitoring or checking that the processes are being followed. Next, you provide a means of tracking or logging any problems that may arise and then take actions to improve. Improvement should then result in a revision to the documented process followed by notifying or training those affected by the process improvement. This closed-loop process, which I call the “Circle of Compliance,” should be used to automate compliance with regulatory standards (see figure 1).

Figure 1: The Circle of Compliance

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