21 CFR Part 11 Conformance for Medical Devices
OVERVIEW 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 21 CFR Part 11 validation will be explained. The requirements are composed of technical and procedural aspects. Open, Closed and H ybrid (paper and electronic) systems will be explained. WHY SHOULD YOU ATTEND 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 ...