Magazine Article | June 1, 2010

When The FDA Comes Knocking, Is Your Company Prepared?

Source: Life Science Leader

By Tim Mohn

It’s become clear in the first four months of this year that the FDA is ratcheting up its efforts to protect the American consumer through stricter oversight of the life sciences industry. In both the pharmaceutical and medical device markets, the agency is investing greater time and resources in its review and oversight of individual companies and the industry as a whole, as several high-profile product-related incidents have had significant implications for consumer safety. The signs thus far point to the agency taking a more systemic rather than reactive approach to regulation to avoid these product safety issues. Although the FDA cannot oversee every organization and each product line, this coordinated approach to quality is a commendable effort that companies in the industry should embrace, as a greater focus on safety will ultimately benefit consumers and businesses alike.

One of the ways we can expect the FDA to tighten its oversight of the industry is to increase the frequency of audits at pharma and med device companies, to make certain that manufacturers’ operations are in compliance with all associated regulatory requirements. Although audits are nothing new to many in the industry, the anticipated uptick in these audits as the agency finds new and more efficient ways to perform them will likely catch many companies off guard. This will include a spike in the number of on-site audits performed with little prior notice and may also extend to include remote audits in which companies will submit data electronically.
Either way, it’s more important than ever that pharma and med device companies prepare for these changes by proactively aligning their quality operations to ensure compliance across the enterprise. When preparing for an audit, the use of an enterprisewide approach to quality and compliance management will help companies eliminate the potential for lost information by securely managing all information in a centralized, scalable, and reliable system. Ultimately, this will make it easier to comply when the FDA does perform an audit — either on-site or remotely — while companies that fail to do so run the risk of missing deadlines, accruing hefty fines, and, most severely, being ordered to halt production of new products.

The purpose of an audit is to monitor critical processes, identify gaps, and stimulate companies to improve quality. Most companies have multiple auditing groups that perform many types of audits, and these groups often have a variety of systems in place to manage audits, few of which are integrated as part of the broader enterprise quality, compliance, and risk system. As good as these siloed audit management tools are for making the audit process more efficient, failure to integrate with broader enterprise systems results in additional costs and missed opportunities to improve quality and to reduce risk. Doing so, however, can improve efficiency while reducing change control closure time by automating workflows and implementing parallel review and approval processes. Integrating audit management as part of a broader quality and compliance management initiative can help pharma and med device companies streamline quality processes, consolidate redundant systems, and reduce manual operations — all in the interest of ensuring greater consumer safety.

Signs now point to the life sciences industry experiencing significantly greater scrutiny from the FDA in the coming months, but the increased frequency of audits can only have adverse effects if companies let it. Pharma and device companies can prepare for the impending uptick in audits by proactively leveraging an enterprisewide approach to audit management, integrated with their quality and compliance management system for centralization and reconciliation of required audit data. Using this approach will reap benefits far beyond simply ensuring compliance with unforeseen audits — it will also help to minimize risk, streamline quality processes, and reduce safety issues, enabling companies to maintain and protect brand integrity by ensuring the production of higher quality products.

im Mohn is an industry principal in Sparta Systems’ product management group. Previously, he served as manager of worldwide quality systems at Ortho Clinical Diagnostics, a Johnson & Johnson company. He is a recognized expert in the field of business process engineering and IT system implementation.