Insights

Co-founder, Jaime Velez, shares his thoughts on how we can enable quality leaders to play an important role in the success of Quality 4.0 programs.

Co-founder, Jaime Velez, covers two steps life sciences companies can take to turn the outcomes of quality system document reviews into actionable insights.

In MasterControl’s GxP Lifeline blog, Co-founder, Jaime Velez, provides his insights on how companies can leverage current Quality Management System (QMS) document review procedures to access and use valuable quality data.

Co-founder, Jaime Velez, presents at the 2022 Pharma Manufacturing World Summit where he discusses the current Quality 4.0 environment and how we’re applying what we’ve learned to help companies transition to continuously monitor the health of each component of their quality system with predictive and behavioral analytics.

Co-founder, Jaime Velez, presents at the 2021 Biomanufacturing World Summit where he addresses the most common Quality 4.0 challenge of how to get started, and discusses what we’ve learned to help companies begin their quality and compliance digital initiatives while ensuring quick results and getting the most value out of your investments.

“By combining AI and BI, companies can get the best of both worlds – speed and scale. They benefit from the massive data-processing capabilities and speed of computers (AI), combined with actionable, business-impacting information driven by analysis, exception identification and escalation protocols (BI).”

Co-founder, Jaime Velez, presents at the 2021 Pharma Manufacturing World Summit where he discusses how we deployed advanced analytics to identify investigations that may create product availability issues, implemented an automated management alarm and escalation system to accelerate closure of those investigations, and leveraged the outcomes of quality system document reviews to assess multiple dimensions of compliance risk.

This whitepaper addresses how BI, delivered by way of real-time aggregation of data, encourages business transformation by enabling executives and managers to be more pragmatic in their decision-making.

This whitepaper describes our 5 rules of engagement for breakout performance that are designed to assess how someone is performing right now, while also providing the tools, skills, and encouragement required to continuously improve.

Outsourcing in the pharmaceutical industry, until recently, has been largely confined to commercial manufacturing, packaging, and support for clinical trials. The industry is rapidly changing; companies are facing rising costs, a fast evolving global market, and weak pipelines.