About Praxis Life Sciences
At Praxis, we've been there; we've done it. We've planned, managed, and executed validation projects for a number of pharmaceutical, medical device, clinical research companies, and even Institutional Review Boards. We know what works, what doesn't, and where mistakes are commonly made. We've designed the standard operating procedures, guidelines, and templates that companies have successfully used to pass FDA audits.
From a recent FDA Warning Letter
"Software validation activities for computers or automated data processing systems used as part of production have not been performed or documented [21 CFR 820.70(i)]. Specifically, the Eng MagMRI software used for engineering and servicing of the MagneVu 1000 MRI System has not been validated."
According to the Food and Drug Administration, software defects led to 242 medical device recalls in only six years. Of these 242 recalls, nearly 80% were due to poor software change management. FDA - and good corporate citizenship - requires software validation and good software engineering practices as principal means to combat software-related defects.
Computer system validation is an important obligation in pharmaceutical, medical device, and clinical research organizations. Software failures have impacted patient safety and led the FDA to implement tough regulations. Warning letters and 483s routinely cite deficiencies in computer system design, development, implementation, and ongoing management.
Validation does not have to be a "dark and stormy night." Sure you can read the regulations. You can even go to a class that teaches you what the regulations say. But you are often left with an empty feeling -- "Yeah, but what am I supposed to do?" That's where Praxis can help. Our workshops, combined with the power of
Validation CenterTM will give you the information, hands-on experience, and tools you need to be successful.
Our Curriculum
Our computer system validation curriculum is divided into three levels.
Level 1 focuses on awareness of the essential elements of computer system validation (including 21CFR Part 11).
Level 2 focuses on building competency in computer system validation through hands-on practice.
Level 3 provides specialized training for Project Managers working on validation projects and validation leaders needing practical instruction in the risk-based approach.
Whether you are new to computer system validation or an experienced pro, our training workshops will give you the information, insight, techniques, and tools you need to be successful.