In my experience, most companies share some combination of the same challenges - too many deviations, too many documentation errors, ineffective training, wordy, non-user focused SOPs, tedious or disorganized onboarding, poor investigations and CAPA, deviation and change control closure issues, etc.  All lead to high error rates, firefighting, high turnover, resource strain, more errors and firefighting, then low morale, a blame culture and more turnover. It's a vicious cycle. Sound familiar?

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Small and mid-size companies approaching late clinical or commercial phases need risk-aware employees with strong knowledge and core skills in cGMP, Data Integrity/GDP, and other quality systems, as well as robust technical training. Yet many firms lack the internal expertise or resources to establish these programs. 

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Having worked in these situations for many years, including 3+ in Cell & Gene Therapy, and 5+ remediating consent decree, I've developed a playbook of practical, sustainable solutions that are aligned to the speed of your business. They will stop the vicious cycle and put you on the path from correction to prevention. It doesn't require new software, or validation, or even change control in many cases; just a small investment, and readiness to change. This makes our solutions practical, sustainable, efficient, and cost-effective.

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