Day

September 14, 2000
Oak Rubber Inc. 9/14/00 Examination gloves A failure to validate the manufacturing process and the computer system used to maintain the product inventory and shipping information. FDA New Orleans District SoftwareCPR Keywords: production software
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Crystal Medical Technology 9/14/00 Dental Implant Devices The inspection revealed deviations from Part 820 including failure to have a manufacturing validation study protocol and to validate software manufacturing equipment and the autoclave sterilization cycle, failure to conduct internal audits, incomplete Device Master Records and Standard Operating Procedures, no Design Plan, no change control procedures and...
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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 training@softwarecpr.com for more info.

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