תעשיות ביו-טק ופארמה2021-07-29T21:40:55+00:00

מאמרים בנושאי פארמה וביו-טק

Validation – What is it?

Articles, איכות ו-GxP, ולידציה והסמכות, מאמרים חדשים, מכשור רפואי, פיתוח מוצר ותהליך, שיפור והתייעלות|

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 שנוצרו [...]

MRI Technology, Validation & Regulatory Requirements

Articles, Engineering & design, Medical Device|

What is MRI?  MRI is a non-invasive medical device that combines medical software for imaging techniques that produce three-dimensional anatomically accurate images. It is usually used for infection detection, [...]

Cosmetics product registration and submission in Israel

Articles, Cosmetics, Dietary Supplements, Supplements|

Guidelines for the process of cosmetics registration/submission in Israel The Department that is responsible to assure the safety and quality of cosmetics products for the Israeli market is the [...]

Corrective and preventive action (CAPA) system

Articles, Phama/BioTech, Phama/BioTech, Phama/BioTech articles, Pharma & Biotech|

Introduction "Nonconformity" investigation is a very common term used in production and product quality improvement areas in the pharmaceutical and medical devices industries. It is mandatory and a regulatory [...]

CE Annex 11, FDA 21 CFR Part 11: Computerized systems and software validation

Articles, general articles, Phama/BioTech, Phama/BioTech, Phama/BioTech articles, Pharma & Biotech|

What is software validation? Software validation is part of the computerized systems validation (CSV) process. Computerized systems validation is defined as documented evidence with a high degree of assurance [...]

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