Are the reports different and will the FDA accept a “new” format?
The report format is different from the Digi report format. There is a report generator which provides much more flexibility. Reports are generated in an easy-to-read style and are built from protected files that cannot be used if tampered with. Customers still have the option of importing the raw data into a spreadsheet and reformatting. All of our feedback from the FDA indicates the report format is not important to them. They are more concerned that critical parameters and data are present and signed by the employee responsible.
