21 CFR Part 11 Conformance for Medical Devices
This Webinar will explain what 21 CFR Part 11 is? Why it is important for 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 also be explained.
Origin of the regulation and changes in interpretation; electronic records; electronic signatures; data security; open, closed and hybrid systems; validation methods; risk analysis.
Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s 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. However, 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 hangouts.
- Engineering personnel
- QA
- IT
- Management
Edwin Waldbusser, is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.
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