Somerset Medical Center Blood Bank

Somerset Medical Center Blood Bank 5/29/96

1. The validation of the Meditech Computer System is incomplete and/or inadequate for the following reasons:

a. Computer documentation did not include testing procedures, system requirements, and system specifications which were specified to Somerset Medical Center.

b. There is no assurance that all program changes resulting from the software upgrade (Version NPR 4.3) were identified and tested prior to the 7/31/95 implementation.

c. Validation documentation for changes made to the [purged word] computer system was not available. For example, a calculation hook to quarantine units was created and implemented in 8/95; there was no validation documentation for this change.

d. Testing was incomplete in that it did not always include invalid and/or “worst case scenario” entries. For example, the testing documentation for the unit status issue routine did not include the attempt to issue “contaminated” and “quarantined” units.

e. Testing documentation did not always include supporting documentation as required by the LIS Validation Testing Protocol. For example, the computer validation form dated 4/11/95 indicated that the ability to reuse social security numbers was tested and acceptable; no documentation supporting this conclusion was attached to the form.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@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) and Italy.