To help assure product performance, FDA has enforced a policy of annual batch reviews for many years. These product reviews which are comprised of analytical results, customer complaints, product investigations, returned goods, and company policies for reviewing the data, are usually checked during FDA inspections.
The collection of the data required for these reviews has, in the past, been an end of the year project requiring many hours and allowing only an after the fact analysis of the data. With the use of a real time data analysis system, the "Annual Review" becomes a "Current Review" allowing for a more immediate reaction to production trends. Data, graphics, and statistical information are available at the click of a button. Our Annual Product Review software is 21 CFR part 11 compliant.