Challenge
This company’s environmental monitoring department did not have well documented procedures for collecting environmental samples, and did not comply with FDA requirements.

Solution
Developed and implemented new environmental monitoring processes, procedures, and systems that are FDA-compliant.

Benefits
Significant benefits of the new solution implemented by Clarkston included:

		Increasing the number of lots released per week from an average of 5 to 15
		Customers receive product according to schedule with product sterility assurance
		Environmental monitoring information is now included as part of lot records, as required by the FDA

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