Medical Information Tech Blood Bank Software

Medical Information Technology 3/6/97 Blood Bank Software Manufacturer

c. Quality Assurance audits do not cover any quality assurance activities associated with the software customization program.

4. Failure to establish an adequate complaint handling program for the [purged text] as required by 21 CFR 820.198 in that complaints are not reviewed by a formally designated unit and complaints which relate to a possible hazard to safety are not kept in a separate portion of the complaint file.

5. Failure to establish an adequate personnel training system as required by 21 CFR 820.25 in that there is not documentation of training and personnel are not aware of the GMP and MDR regulatory requirements under which your firm is required to operate.

6. Failure to assure that the device specification changes are subject to controls as stringent as those applied to the original design, as required by 21 CFR 820.100, in that software defects were identified by users rather than identified during your software validation activities. Examples of these defects include such significant software elements as donor antibody history, ([purged text]) and donor blood type ([purged text]).

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.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

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