complaints Posts

Deviation Management and the Next Level of GMP Compliance

Deviation Management and the Next Level of GMP Compliance

Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality Solutions

Despite the best efforts of industry and regulators alike, quality issues are on the rise. Product complaints are up, along with product recalls, drug shortages, product bans, plant shutdowns, and enforcement actions. This means that industry and regulators alike are looking for answers.

Fortunately, many of these answers lie within your existing deviation management processes and data. The key is understanding the true driver behind Good Manufacturing Practices (GMP), and then structuring your deviation and quality management processes accordingly.
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Quality Risks: Use Quality System Data to See the Big Picture

Quality Risks: Use Quality System Data to See the Big Picture

Kevin Lee, Industry Solutions Manager, Pilgrim Quality Solutions

On a day-to-day basis, most of us are busy taking care of the details. We’re fixing problems as they happen, checking things off to-do lists, and responding to emails. But as we move through our busy days, most of us are aware of the periodic need to take a step back, look at the big picture, and assess our progress against our goals. That high-level look often reveals trends that need to be reinforced or changed as we move forward. Nowhere is this truer than within a quality system. The seemingly small or micro details that we work through each day add up with other processes and details to form the bigger (macro) picture of our organization’s risk.
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Medical Device Complaint Handling: If you can’t stop the complaining, start the efficiency gaining.

Medical Device Complaint Handling: If you can’t stop the complaining, start the efficiency gaining.

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Complaints can come from anywhere; it’s what you do with them that matters.

And when it comes to reportable events, time is what matters most. The clock begins ticking the moment your organization becomes aware of a complaint. Having an easy-to-use, intuitive medical device complaint handling system can make all the difference when you need to quickly get information to the FDA CDRH or any other regulatory body. Your organization may never be able to fully eliminate complaints, but it can improve their handling.

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