1. If the FDA comes to your site and wants to know where a shipment came from, can you provide a definite answer within 24 hours?
2. Do you have an effective policy in place, backed by the right tools, to make certain you are keeping the records you need to keep for the length of time required by law?
Ironically, says Eric June, chief software architect at AssurX, some firms make their biggest mistake by going overboard and keeping everything. "Instead of being in better shape with regulators, they make it harder for themselves when a federal regulator comes to get a specific record."
Retaining records is essential. Equally important, however, is controlling your records and being aware of the latest updates to the Bioterrorism Act. Next month Food Engineering will publish a detailed report to help processors understand the implications of the act and the actions they must take to be in compliance. For the latest update on the BT act as of February 23, 2005, visit www.fda.gov/ohrms/dockets/98fr/05-3424.htm.
For more information about AssurX, visit www.assurx.com.