Today, CEOs face the daunting challenge of competing in global markets and are employing highly effective strategies to out pace their competitors to create greater profitability.

If you’re thinking of CFR 21 Part 11 compliance in terms of what the FDA may or may not require, you’re missing a huge opportunity to make your business more efficient, nimble and ultimately profitable by improving the quality of your operation and its products.

Companies whose products are regulated by the FDA, especially pharmaceutical and medical device companies, stand to increase their workable ROI by millions of dollars with quality system technology that accelerates innovation and streamlines compliance.

Think about your business environment—that broad network of relationships and interactions that make up your business. It encompasses the people and systems inside and outside your organization.

In recent years, the life science industry and healthcare organizations has given greater priority and attention to quality assurance and regulatory compliance than ever before.  With the FDA’s heightened focus on safety, regulatory agencies are increasing their presence in the manufacturing arena to ensure Current Good Manufacturing Practices cGMP are top of mind.

With the growing global economy, the risks of im­ported products are increasingly shared by countries around the world. Now more than ever, effective pub­lic health protection requires a range of stakeholders, including government agencies, industries, academia, non-governmental organizations, and scientific com­munities, to work together in partnership toward a single goal: protecting public health worldwide.

Quality Management Systems are structured around interlinked processes that provide the necessary implementation controls to ensure customer and regulatory requirements are met and continual process improvement. 

In a Special Report by the FDA titled, Pathway to Global Product Safety and Quality, the FDA has been a recognized world leader in product safety standards. As the agency looks to the future, it can no longer rely on the historical tools, activities, and strategies to regulate products.

Regulated pharmaceutical, biotech and medical device companies are challenged to develop manufacturing capabilities quickly and cost-effectively while at the same time safeguarding product quality and patient safety.

In a recent article written by Erica Brooks and Yasmeen Muhammand, of Compliance Implementation Services, for PharmaManufacturing.com, the authors write about “ a company’s quality system is only as good as the people managing those systems".