Software assists regulatory compliance
Staff -- Control Engineering, 5/1/2001
Foxborough, Mass.— Intellution recently announced the availability of iBatch 4.5 and iWorkInstruction 1.0—two new tools designed to help FDA-regulated businesses achieve 21 CFR Part 11 (electronic signatures) compliance. Significant among the enhancements included in iBatch 4.5 is the addition of an OPC (OLE for process control) Soft Phase server designed to implement batch functions, such as prompts and reminders for manual processing steps and assay calculations. Another iBatch enhancement is inclusion of iWorkInstruction 1.0, a client-server means of combining and storing automatically and manually generated batch data into a common batch record. iWorkInstruction authoring functions can be integrated using the included recipe editor or stand-alone tools, and are stored in easy to manage XML file format.
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