Novatek International

The Raw Material Analyzer module is a software application that is used to facilitate the testing of Raw materials and incoming Packaging components. The Software consists of the following windows: Product Registration, where the user can input pertinent information regarding the product and the type of packaging used in shipment of the Raw Materials; Monograph, where the user can define the required tests; Certificate of Analysis: used for entering, verifying and approving the data; The Approved manufacturers and Suppliers list; where the user can verify that the product is from an approved source; Investigation; where the user can initiate an Out of Specification Investigation. The trending of lots is possible to ensure that the raw material manufacturing process is under control. The Raw Material module is 21 CFR part 11 compliant and has an extensive, independent audit trail.