North American Science Assoc Contract Testing Lab

North American Science Assoc 11/24/98 Contract Testing Laboratory

Failure to maintain adequate controls over computers and related systems to assure that changes in the master production and control records or other records are instituted only by authorized personnel [21 CFR 211.68(b)]. For example: (1) there is no current listing of individuals who have access to the Customer Service Unit’s _____ database program or to what level of access each individual has; (2) there is no procedure in place to grant, modify or remove access privileges to this software (FDA 483 observation 1 d&e).

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.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.