Anabolic Inc.

… Failure to ensure that automatic, mechanical, and electronic equipment, including computer(s) are inspected or checked according to a written program designed to assure proper performance [21 CFR 211.68]. For example, your computer software used for tracking raw material, finished product quarantine/release, and archiving master formulas has not been validated….
SoftwareCPR Keywords: Drug, Pharma

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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