How To Audit Contract Manufacturers For Data Integrity Breaches
With data integrity problems on the rise, pharmaceutical manufacturers must ensure in auditing their contract manufacturing partners that they have the robust electronic controls needed to survive an FDA inspection. The analytical lab is a good place to start when doing audits because it's where a majority of problems are found by FDA investigators.
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FDA official advises starting with laboratories when auditing contract manufacturers for data integrity. Recent warning letters and WHO notice of concern show why.
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