Among the many regulations overseen by the Food and Drug Administration, there is one pertaining specifically to electronic records and signatures generated by computer systems - 21 CFR Part 11. The FDA's purpose here is to ensure that electronic records and signatures are trustworthy, reliable and compatible with the FDA's mission of safeguarding public health. Section 11.10 of the regulation requires procedures and controls to be put in place that "ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records". Intelex offers a validation pack that is designed to test your system's compliance to these requirements. For more information, please contact an Intelex representative.
