Revolutionize Pharmaceutical Startup Quality Management

Medical advances increase life expectancy but new drugs and therapies enable quality of life. 81% of new drugs are not developed by large drug companies but by startups. Startups are a critical pipeline for new drugs. New technologies are improving research and manufacturing, yet we live with high risks to quality and slow manual process. We are innovating expert systems (AI) and automation to truly optimize paths to FDA compliant drug approval.

Red Pascual CEO @ CALIDAD.AI

Shortly after I returned from conducting an audit on a pharmaceutical manufacturer, I found myself frustrated with how manual the whole experience is. As an auditor, I have 8-16 hours to inspect a facility, comb through hundreds of pages of documentation, and find a needle in a haystack that is a regulatory observation across more than 20 quality systems. The primary tools I use are my pen and paper for notes, and my 10+ years of experience, which may not include 100% of the systems I have to inspect. I have to follow up on open questions and turn my notes into an official audit report, which can take me 30 days after an inspection.

I asked myself, why is auditing so difficult?

Auditing is critical during several phases of drug development. It seems to me like everyone in other industries has been benefiting from mobile apps and online tools to help them with important work. Still, pharmaceutical auditing is stuck in the dark ages! I shared my experience with my friends from the software industry. We did our research, and in January of 2019, we got to work on solutions.