Was the Safety System an Adverse Event?

The Practical Solutions Group, LLC was retained by a CRO to validate their safety data management system, which is used to collect Serious Adverse Events (SAEs) data, track SAEs and populate the appropriate MedWatch form. We were assured that robust system testing was performed by the developers prior to validation and that the system was ready to be validated.

While performing discovery activities to gain an understanding of the system, we observed numerous issues with the system's design and functionality which would result in non-compliance to 21 CFR part 11 and GCPs. When we learned about these issues, we suggested to the client's management that a stop be put to the validation effort until the developers fix the problems. The issues were so significant that the client's management expected that it would take weeks until the validation project could be resumed.

We immediately took a proactive stand on the issue: in order to avoid any further delays with the project, we met with the lead programmer to 1) communicate the nature and severity of the regulatory issues face-to-face and 2) gain an understanding of the time that would be required to correct them. Once we interpreted the regulations of 21 CFR part 11 and GCPs for the lead programmer and explained what the industry expectations are, he said, to our surprise, that these issues could be corrected within a matter of days rather than weeks, as everyone initially thought.

At the end of the day, the project was completed on time. We had to work long days and over weekends to make sure of that, but so what? It was all worth it because, six months after the system went live, we received an e-mail from the programmer that stated, and we quote: "☺ the system is working perfectly"...