We have used their report to revise our training and documentation procedures as well as modify our product development plans. The following assessment is based on their report.
Durable media is defined as tape or disk type media .
When data is committed to durable media, such as tape or disk, it is at that point an electronic record has been created. Dissolution Tester, VK 8000 Autosampler and the Bio-Dis Extended Release Tester. Each piece of equipment has a programmable interface to allow setup parameters to be entered by the operator for the test method. The VK 8000 has the ability to store up to 20 different methods, while the other instruments maintain one method. Based upon the durable media definition, the battery backed-up memory chip has not been interpreted in the industry as durable media.