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The A to Z of Quality Systems Remediation

A company facing a laundry list of observations at the end of any regulatory inspection will likely react with great energy and purpose to fix each one.

This reactionary approach will likely lead to disappointment upon the next regulatory inspection when the inspection reveals additional examples of the same or similar problems. It can rapidly become a repetitive cycle of failures resulting in chronic quality system/GMP non-compliance. This happens when the company focuses on the symptoms rather than the underlying causes. If the underlying systems are not corrected, inspection after inspection will identify examples of the same system weaknesses.

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