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Case Study Example:
RCM supported a pharmaceutical startup in commercialization by rationalizing IT SOPs and ensuring Computer System Validation readiness. Over 18 months, RCM identified gaps, developed critical SOPs, and implemented controls in GxP, Vendor Management, and Data Integrity. Using Veeva QMS, RCM ensured FDA and EMEA compliance, creating data protection SOP and data governance policies. The project resulted in 100% regulatory compliance, enhanced document management, and a training program for ongoing policy upkeep.
Client Testimonial:
“RCM played a critical role in preparing our company for
commercialization. Their expertise in data governance, rationalizing IT SOPs and ensuring regulatory compliance with FDA and EMEA standards was invaluable. Over the 18-month project, they developed key SOPs, implemented robust data governance framework with necessary controls, and set up a robust training program, ensuring 100% compliance and streamlined document management. Their support has been crucial for our successful transition." — Chief Compliance Officer, Pharmaceutical Startup
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