Use Formal Compliance Feedback Mechanisms to Avoid Overly Strict or Loose Policies
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Formal Compliance Feedback Mechanisms Avoid Overly Strict or Loose Policies

Compliance is a necessary part of doing business (very necessary for bio/pharm), but sometimes it goes a shade too far. When asked what single factor he would change about compliance efforts at his company if he could, a compliance executive from a top pharma company responded with one word: simplification. At a previous company, the compliance team dictated SOPs for seemingly everything. These SOPs were written with a level of detail that made the process of creating, reviewing, finalizing and approving all of those control documents a significant effort.

Later he arrived at a position with a new company that applied the opposite approach. Far fewer SOPs were in place, and the company would address minor issues with instructional documents. The SOPs themselves were much shorter in length — but they were too flexible and not detailed enough. The executive found the loose compliance as troubling as the strict SOPs at his previous employer. “It is difficult to find the right spot between the very detailed and onerous approach to control docs and processes and the very loose and flexible approach,” he said. “If you can find that sweet spot in the middle it would be very valuable.”

To combat over- or under-restrictive policies from damaging operations, many pharmaceutical compliance teams implement compliance feedback mechanisms into their programs. Many companies request feedback from their field forces, for example, to avoid hampering efforts on the ground.

Likewise, they might ask sales reps and MSLs to gather pharmaceutical competitive intelligence about the guidelines under which competitors operate for comparative purposes. If sales teams and MSLs report that their companies’ standards reach far beyond or far short of the norm, the compliance group would certainly look to bring policies closer to the middle. Though feedback does not always cause compliance groups and executives to alter company guidelines, it is at least considered within the compliance framework. Not considering employee feedback is a recipe for stagnation.

Companies gather feedback in a number of ways. Ride-alongs by compliance team members with field forces provide significant feedback loops. Open communication lines — via 1-800 numbers or simple “open-door” policies — also keeps communication flowing. Another avenue compliance departments find successful is a simple survey of internal teams. Ultimately, companies that encourage feedback from all levels of the organization ensure that their compliance guidelines are fair, balanced and reasonable.

Adam Bianchi
Senior Director of Research and Client Relationships

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Pharmaceutical Compliance Best Practices
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Pharmaceutical Regulatory Affairs

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