The Quality Assurance Department maintains a secured documentation system which includes a change control process for each document that is created or modified. All documents are maintained in a secured computer server. All old documentation revision is archived and stored as required by the FDA. Quality Assurance Department provides the customer a Certificate of Analysis (C of A) on all approved product that is manufactured at the plant. The C of A contains the Lot code, test results, expiration date, manufacturing date, and quantity approved.
