North American Science Contract Test Lab

North American Science Contract Test Laboratory 11/24/98

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 xxxx 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).

Failure to maintain complete data from all tests necessary to assure compliance with established specifications and standards [21 CFR 211.94]. For example:
(a) The Customer Service Unit’s (CSU) xxxx database program which generates the sample test worksheets that are identified by sequential sample numbers, allows for the multiple printing of these worksheets. Copies will have the same sample number as the original without any indication which version is the original and which is a subsequent copy. Further, there is no audit trail within the computer that identifies how many worksheets have been generated for a given sample number (FDA 483 observation I.1f).

SoftwareCPR keywords: Software validation, security, drugs, pharmaceuticals

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.