Today, more than ever before, frequent and more intensive supplier audits are critical to ensuring supply chain integrity. Globalization, increased product complexity, outsourcing, and expansion into emerging markets have prompted regulatory agencies, particularly the FDA, to take a closer look at how manufacturers manage their suppliers. Those who utilize the services of contract manufacturing organizations (CMOs), clinical research organizations (CROs), and other third-party vendors must be ready to endure more import-related inspections, as well as toughened penalties for violations. A company's ability to withstand this increased regulatory scrutiny, and maintain its brand equity, will depend largely on the efficacy of its supplier audit program.
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Implementing a comprehensive supplier audit program to qualify suppliers yields many benefits to regulated organizations, such as improved efficiency, product quality, and profitability. However, today's increasingly global supply chain makes it difficult to develop and execute such a program - especially when managing tens, hundreds, even thousands of third-party providers, many of whom collaborate with different departments and geographically dispersed divisions across the company. Nevertheless, in the view of regulatory agencies, product safety and efficacy are the manufacturer's (not the supplier's) responsibility. Unfortunately, many companies are at a loss as to where and how to begin when it comes to designing an effective, yet sensible supplier audit program - one that maintains audit quality but does not waste money auditing suppliers who pose little risk. A good place to start is to examine the key elements of the most effective supplier audit programs:
It's inevitable: more diversity in the supply chain yields greater risk, and the only way to minimize that risk is by conducting frequent, more intensive third-party audits as part of a sound, enterprise-wide supplier audit program. The MasterControl software solution provides a framework that helps regulated organizations manage their suppliers successfully, as well as the tools to make it easier for them to communicate and collaborate with one another. Here are some of the features MasterControl offers to address the challenges mentioned above:
To learn more about supplier audit program, please feel free to contact a MasterControl representative.