GxP Lifeline: Stop Throwing Away Valuable Data From Quality Management System Document Reviews and Start Using It

Co-Founder, Jaime Velez, provides his insights on how companies can leverage current QMS document review procedures to access and use valuable quality data.

PMWS22 Workshop: Quality 4.0: Making the Shift to Continuously Monitor the Health of your QMS

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.

BMWS21 Workshop: Quality 4.0: Where Do I Start?

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.

PMWS21 Workshop: Leveraging Predictive and Behavioral Analytics to Ensure Supply Chain Health and Assess Compliance Risks

Co-Founder, Jaime Velez, presents at the 2021 Pharma Manufacturing World Summit where he discusses how we deployed advanced analytics to identify recently launched 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.

Generis Group Interview with Co-Founder, Jaime Velez

“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).”

Whitepaper: Implementing Pragmatic Decision-Making

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.

Whitepaper: 5 Rules of Engagement

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.

Whitepaper: Smart Outsourcing

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. 

Quality By Design eBook

This Q&A eBook delves into: three batch validation; regulatory compliance in product development and quality systems; and how to lead an integrated QbD implementation strategy.

Case Studies