For pharmaceutical, biotechnology and medical device companies charged to do more with less as a result of consolidation, restructuring and economic uncertainty, recent years have presented extraordinary regulatory and quality compliance challenges. Without the right attention, these challenges can weaken quality systems and processes, erode domain and critical thinking expertise, and cause core quality principles to be neglected – leaving companies vulnerable to compliance lapses and enforcement action. These issues are only exacerbated with the disparate systems that result from outsourcing or mergers and acquisitions.