Medical Device industry2020-06-02T10:29:42+00:00

Validation for ERP Priority and SAP systems at Pharma and Medical companies

מהי ולידציה למערכות ERP פריוריטי? מערכת ERP היא מערכת ממוחשבת לתכנון משאבי הארגון והיא נמצאת בשימוש כמעט בכל העסקים והארגונים הבינוניים והגדולים בעולם, אך גם בשימוש של חברות קטנות Read More >>>

חשיבות ה- Data integrity בחברות תרופות

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 Read More >>>

Good Storage and Distribution Practice (GSP/GDP), cold chain safety and validation

Background Good Storage Practice (GSP) and Good Distribution Practice (GDP) describe human, veterinary and investigational drug substance and drug product supply chain procedures and standards for assurance of the Read More >>>

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 regulatory Read More >>>

Tips for choosing the right cleaning agent for production equipment in the pharmaceutical and medical industries

Cleaning processes in the pharma and medical fields Cleaning processes that are developed and used in the pharmaceutical, medical, cosmetic, and food industries must be both effective and proven, while Read More >>>

Medical devices Cleaning Validation

GA 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 and have Read More >>>

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 Quality Read More >>>

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