Identify a Practical Approach to Compensate for a System Improperly Developed and Validated.

The Practical Solutions Group was asked to assess the development processes and validation status of a home-grown system that supported randomization number assignment and drug kit distribution. Company management had the sense that the system was not operating properly because of a large number of required bug fixes and enhancements in a relatively short period of time and wanted confirmation before the study was very far along.

In the process of assessing the system's status, we determined that the system was "retrofitted" to meet the company's requirements in the absence of user requirements and an understanding of regulatory requirements or expectations. The large number of enhancements was necessary because user requirements were not addressed initially. The large number of bug fixes resulted from improper development, testing techniques and lack of user training. Additionally, the changes were made in the absence of a formal change control methodology.

A 100% QC was performed on the randomization assignment and drug kit distribution data not long before the assessment and no data deficiencies were uncovered. Nevertheless, not addressing the existing system deficiencies will present the on-going risk to data integrity. We also pointed out that continuing to perform QC reviews to ensure data integrity, rather than validating the system, would mitigate the problem but become cost prohibitive over the life of the study. This would not be a very practical approach to take.

The practical remedy that was suggested is:

1. Collect existing documentation, including the results of the QC review, and lock it down.
2. Collect user requirements and develop a new version of the system based on these requirements.
3. Validate the new version using industry-standard validation disciplines.
4. Consider this version of the system as the validated baseline and make changes only thru a formal change control procedure.

So, a spoonful of practicality made the business risks go down.