-
Chris Vasquez replied to the topic Making up tests for design verification and validation in the forum Introduction to Design Controls 8 years, 7 months ago
As many have mentioned before verification and validation often come hand in hand, and they sometimes are used interchangeable, but they are different. Combined verification and validation of engineering designs within the product lifecycle directly influence production performance, define product functionality, customer perception of the product,…[Read more]
-
Chris Vasquez replied to the topic What are Design Controls? in the forum Introduction to Design Controls 8 years, 7 months ago
Design controls are required by the FDA and are implemented to ensure traceability on released products. The idea is that if the released product has a defect which interferes with its function and effects the consumer, all history is traced from raw materials used in the construction of the device to the manufacturing of it. If there is an…[Read more]
-
Chris Vasquez replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls 8 years, 7 months ago
Design controls are essentially implemented to ensure traceability on their released product. The idea is that if the released product has a defect which interferes with its function and effects the consumer, all history of the product from design to manufacturing is traced, which could be found in a Design History File, in other words design…[Read more]
-
Chris Vasquez replied to the topic Design Verification & Validation in the forum Introduction to Design Controls 8 years, 7 months ago
In terms of verification it can be a considered a form of quality control in which processes, services or documents conform to specified requirements or regulations from the vendor, which may also be attributed within Installation qualification, which ensures that equipment that is installed meets all specifications, and is installed correctly,…[Read more]
-
Chris Vasquez became a registered member 8 years, 7 months ago