Client Business Situation

Client Company had experienced multiple enforcement interactions with the US Food and Drug Administration in its recent history. As a result of a number of specific, related enforcement activities, client’s business operations were being significantly impacted with revenue and profitability down sharply. When Client Company initially approached Compliance Architects^® for assistance, it was engaged in the direction and management of a large number of individual compliance remediation projects, in addition to multiple enforcement response activities. The Vice President of Quality responsible for North American operations was the budget owner for all remediation and response activities. As is usual in these cases, despite significant enforcement risk exposure, the client executive had a fixed amount of expense money in the budget for remediation efforts. Even given the large amount of projects already being funded, the client company had many additional remediation activities that needed to be evaluated for prioritization and execution.

Client Business Pain

The Client Company had no formal method of assessing the large number of projects, activities, initiatives, remediation changes, etc. that were potential candidates for funding. There was no structured way to determine the best allocation of budgetary resources for “return on compliance investment”. Further, there was no method to assess prioritization of either compliance risk, or complexity (cost) of the resulting remediation program. This lack of structured ability to prioritize risk for remediation projects resulted in a “house on fire” approach to remediation. Resources were massively overworked, priorities shifted daily, and all activities were behind schedule and not meeting expectations.

Solutions Provided / Services Delivered

Combining expertise and an innovative approach in how to determine relative FDA enforcement risk along with sophisticated SharePoint configuration capabilities, Compliance Architects^® developed and implemented both a methodology and a corresponding computer-based tool that provided the following capabilities:

Proprietary risk-assessment algorithm that yields quantitative measures from qualitative assessments of risk, enabling relative risk comparisons of known compliance gaps;

Proprietary complexity-assessment algorithm that yields quantitative measures from qualitative assessments of cost, complexity, duration and execution difficulty of potential remediation projects, enabling relative complexity comparisons for potential project funding; and

Easy to understand graphical representations of relative risk between potential remediation targets along with corresponding complexity measures enabling Corporate management to objectively identify “low hanging fruit” and substantiate delaying more complex, time-challenging remediation efforts with lower risk profiles.

Benefits Realized

The elegantly simple methodology and corresponding SharePoint tool helped Client Company move from complexity and chaos, to calm. By providing the Vice President of Quality with an ongoing portfolio management tool for compliance remediation projects, and with the ability to quantify relative risk, cost, and complexity, the organization was able to much more efficiently prioritize and allocate its limited resources to reduce risk in a logical, defined manner. The structured compliance risk analysis portion of the tool, in and of itself, helped the company to understand individual areas of enforcement risk exposure to support FDA inspection readiness activities.