December 21, 2006
Recipient: MRL Inc., a Welch Allyn Co..Product:Automatic external defibrillators Date:12/8/06 Failure to have production and process controls for automated processes, as required by 21 CFR 820.70(i). when computers or automated data processing systems are used as part of production or the quality system. A manufacturer is required to validate computer software for its intended use...
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CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email for more info.

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