Right on the Money
The Practical Solutions Group, LLC was asked by two different clients (sponsors) to perform pre-qualification audits of their potential respective software vendors.
Both vendors had the necessary procedures and documentation in place and yet both had the same fundamental issues regarding 1) the generation and maintenance of regulatory-related documentation (e.g., SOPs, training records, validation suite) and 2) overall quality oversight (it was not meaningful or effective in either case). Numerous issues at both organizations (e.g., lack of effective management oversight, poorly trained staff, ineffective Quality Assurance) resulted in documentation of regulatory significance that was poorly worded, inconsistent and/or incomplete. We concluded, and advised our clients accordingly, that the nature and scope of these software- and quality-related deficiencies were so egregious as to raise serious questions regarding the ability of the respective vendor to assure quality of other significant areas of support (e.g., help desk support, change management, maintenance of timelines, effective and timely communications).
Compounding the above, each vendor was in the process of re-organization and aggressively implementing new quality initiatives, which were viewed as necessary to support growth. However, no new resources were devoted to the new initiatives and, given the number of issues noted during the respective two-day audits, it was pretty clear that the vendors could not address all of the issues in sufficient detail to be able to eliminate the respective regulatory issues observed.
We suggested to our clients that they not formalize the respective business relationship with the respective software vendors and instead recommended alternative third-parties. Our vision proved to be right on the money: as time passed, we heard numerous complaints about these software vendors from their customers, with some of the customers in fact ending their relationship with the given vendor. We are quite proud to have been able to gaze into future without a crystal ball and help our clients avoid serious problems.