by Faith Fraley, Director, CQV Engineering at Kymanox Every pharmaceutical manufacturing facility requires a controlled manufacturing environment. Temperature, humidity, and pressure are crucial to products and processes. Deviations can be disastrous, but environmental controls mean nothing if they aren’t properly qualified and validated. A programming issue with humidity controls could …
Jim Falanga, Director, CSV Compliance Tara Doby, Sr. Validation Specialist Regulatory agencies, such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require life science companies to have controls on computer systems that are used to manage CGxP electronic data and records. As part of the implementation and maintenance …
Enforcement of Part 11 and Annex 11 varies, but electronic data integrity is something that cannot be compromised. Our experienced Part 11 team has tackled many firsts in the industry, for example, iPad apps and cloud-based systems.
