Blog

Many medical device companies have struggled with implementing a risk management process that results in risk being mitigated to the level of AFAP.

AR-driven hands-free validation isn’t just a futuristic concept; it’s available now. In this insightful Q&A, Steve Thompson discusses how it will transform GMP production environments.

The ICH released a draft version of the new ICH Q14 Guideline last March. This blog post will give you an overview of its key implementation aspects.

ValConnect 2022 is off to a great start! Today's agenda featured live product demos and a keynote from Roche/Genentech. Here's a recap of day one.

Traditional commissioning and qualification can be very challenging due to the inefficiencies, compliance risk, lack of data integration, inability to adequately track and close out activities.

The upcoming transition from CSV to CSA models reduces the cost of validation and provides a more risk and science based approach.

This current era of biopharmaceutical manufacturing is a most challenging and exciting time for our industry. Technology breakthroughs, intensifying competition, and continually rising performance expectations from patients, stakeholders, pressure from government bodies for cost reduction, and regulators necessitate rapid change in execution.

In our journey to instill quality culture across life sciences, we've learned several valuable lessons along the way. The bottom line: continued training and development matters more than ever.

The second stage of the validation lifecycle is called Process Qualification. This stage is customary and is referred to as Cleaning Validation. Usually, three consecutive successful runs are performed to qualify the process using well characterized, well documented and consistent cleaning procedures.

Traditional computer software validation (CSV) focuses on documentation. Computer software assurance (CSA) focuses on critical thinking.