Validation – What is it?
חשיבות ה- Data integrity בחברות תרופות אמינות ושלמות הנתונים, או במונח הלועזי Data integrity מאפשרת הן לחברה והן לגופי הרגולציה אשר מבצעים ביקורות איכות ו-GMP תקופתיות, להבין שהנתונים [...]
Risk Assessment and Risk Management in the Medical and Pharmaceutical IndustriesRisk Assessment and Risk Management in the Medical and Pharmaceutical Industries
Articles, Medical Device, Medical Device, Phama/BioTech, Phama/BioTech articles, איכות ו-GxP, אמ”ר, ולידציה והסמכות, מצוינות תפעולית, פארמה וביוטק
Risk Assessment and Risk Management in the Medical and Pharmaceutical Industries
The medical and pharmaceutical industries are involved in new product development and manufacturing of medicines, medicinal products, biological products, medical devices and combination products. Risk management is a [...]
Medical device cleaning validation
A contaminated medical device may lead to serious implications and risk to the patient/user. Medical device manufacturers must ensure they have correctly identified all potential risks and contaminants [...]
Validation – What is it?
What is Validation? Validation is documented evidence that a process/equipment/system/software/procedure complies with specifications, criteria and requirements which are defined in a pre-approved protocol and detailed in: Specifications Definitions [...]