Amit Dekate

Amit Dekate - Member Profile

Mumbai, India

MSc, Mumbai University
Tenthpin
Infosys
Cognizant
Independent Professional

With over 17 years of experience in the life sciences industry, my expertise lies in regulatory compliance, quality consulting, and computer system validation. As an Advisor at Tenthpin, I contributed to ensuring quality compliance for enterprise IT implementations, focusing on frameworks like GAMP 5 and regulatory standards such as 21 CFR Part 11. My work supported scalable, compliant IT implementations for pharmaceutical, medical device, and clinical organizations.

Previous roles include supporting enterprise systems such as EQMS, LIMS, and MES, as well as providing guidance during regulatory inspections and audits. My career has centered on enabling risk-based approaches for critical IT projects, emphasizing quality assurance and compliance in life sciences to meet global regulatory demands.

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