This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.
FDA-regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient.
FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both.
The confusion over the original FDA regulation and its subsequent "selective enforcement" will be explained. FDA requirements for 21CFR Part 11 validation will be explained. the requirements are composed of technical and procedural aspects. open, closed, and hybrid (paper and electronic) systems will be explained.
Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483s at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11. After industry complaints, the FDA acknowledged that the regulation, as written, would result in nobody attempting to convert to electronic records. But, instead of rewriting the regulation, FDA said it would "selectively enforce" sections of the regulation.
This webinar will explain what all this means. A 21CFR checklist and a Test protocol form will be given as handouts.