Compliance Remediation Projects Needed: Consultants

The FDA Group says that to prevent potentially damaging consequences when things go wrong, manufacturers need to take on effective remediation projects that not only identify the root causes of particular problems, but put comprehensive plans in place to remedy them and communicate the improvements to FDA effectively. In a white paper, the FDA Group defines compliance remediation in medical device and pharmaceutical and biopharmaceutical manufacturing as “the process of recognizing problems and creating a plan to correct and prevent those problems from occurring again.”

The paper makes the point that regulatory agencies such as FDA are less concerned with policing manufacturers themselves, focusing instead on understanding a company’s ability to execute internal quality processes on their own, and how the company’s processes and procedures are used to comply with the respective regulations.

In addition to monitoring sufficient standards for quality, it says, FDA also works to ensure that manufacturers are storing and analyzing quality systems and post-market data effectively while creating comprehensive corrective and preventive action plans when quality standards aren’t met. “When regulatory problems arise,” FDA Group says, “it’s up to manufacturers to find effective corrective actions to prevent recurrence [and] that’s where remediation comes in.”

The paper says that FDA focuses its attention on these compliance streams: corrective and preventive action, complaints, Medical Device Reporting, corrections and removals, design control, change control, management review, and production and process control.

“While remediation can seem like an overwhelming endeavor,” the paper concludes, “simply knowing what regulators are looking for can make a huge difference throughout the entire process. It’s important to remember that each situation is unique and requires a unique approach.”