SMART quality & compliance
LIMS Implementation: Success Factors from a Project Manager Perspective
“Change before you have to.” —Jack Welch A Laboratory Information Management System (LIMS) is software that allows your laboratory to manage samples and associated data effectively. Its primary purpose is to improve lab efficiency and accuracy by reducing manual operations, automating workflows and also managing sample associated information. Most pharma companies whose laboratories perform medical analysis or other testing services require compliant systems that ensure that sample testing can be performed to an acceptable standard which ensures that all data is reliable and accurately reported. After having chosen the appropriate LIMS vendor to your organization, the most common practice to…
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SMART quality & compliance
Sterilization Processes for Medical Devices
What kind of sterilization methods can be used for a medical device? There are different methods for the sterilization of medical devices, using gas and steam or radiation. Radiation methods: The principle of this form of sterilization treatment is to bombard the sample with high energy electrons or high energy electromagnetic radiation. This activity leads to the formation of unstable free radicals, molecular ions, and secondary electrons. These products react with molecules and fracture their chemical bonds. DNA and RNA are sensitives to this sterilization approach. The advantage of this technique is that products can be sterilized through radiation after packaging due to the penetrating power of the incident gamma-ray. Nevertheless, some drugs like heparin cannot be irradiated because there is a risk of changing…
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