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Harsh Thakkar

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On paper, your company’s QMS looks great. A nice software solution, a training program for employees, and you’re partnered with the supplier of your dreams. But something feels wrong. You can’t seem to get a grip on your QMS data relationships. You’ve been working long hours & late nights to ensure the system is validated, secure, and supported— everything the system ever wanted. At first, you ignored the growing pain in your ability to find the QMS data or visualize it, writing it off as a minor issue that will eventually solve itself. Then one morning you woke up and realized things had changed. Gone are the days when you’d spend time crunching data in MS Excel and analyzing QA metrics. A minor issue has grown into a MAJOR problem, and now it’s impossible to ignore that all the effort of capturing and analyzing QA metrics is weighing you down. Your QMS data is all over the place, disconnected, and you’re tired of working harder than you need to. When you ask management for more spending— all you hear is “reduce costs.” So you try asking for access to analytics tools and automation software. It gets some traction but gets shut down due to compliance risks. You've tried: • Updating processes- no result. • Training and hiring experts- didn’t work either. • Building reports and dashboards in your QMS, thinking visibility was the issue- also failed. How did I know? I tried them too in my career and didn't see the desired results. Don't panic. There is hope. You require a QMS framework that can teach you how to manage your QMS data, from the day it's created so you can rely on it when you need to make GxP decisions. Working with my team, you will learn how to: 1. Analyze data sources. 2. Unite your QMS elements so they TALK TO EACH OTHER. 3. Capture the metrics you want, without staring at spreadsheet or using complex formulas. 4. Have a fulfilling role in QA, built on critical thinking and practical methods. Results speak for themselves: "I appreciate Harsh’s depth of knowledge in computer software assurance and his commitment to quality. He often challenges the status quo and explains his viewpoints in a pragmatic way that is easy to understand. Harsh is an invaluable asset to any organization to help foster a culture of data quality and integrity. " - GL I have more of these, but LinkedIn says I'm out of characters. Back to you. Are you tired of failing to get results? Are you ready to make a REAL change in how you approach your QMS data? Then let's talk. DM me here, or shoot me an email at [email protected]

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