White Papers
Our white papers and technical bulletins are written by industry experts from many different fields, exploring and commentating on a range of complex subjects.
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eSource Arising: Clinical Data Automation Possibilities Beyond Data Capture
When implementing the 1st generation of eSource system at SGS, the focus was on facilitating data capture and converting clinical data directly to a Study Data Tabulation Model (SDTM), making eCRF redundant. After getting familiar with eSource, we are now ready to use our knowledge and expertise and take eSource clinical automation to the next level with the 2nd generation of eSource system. This paper will highlight our acquired insights and the challenges faced from both systems, resulting in improved efficiencies. |
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Self-Assessment Checklist for Innovation Management System
This self-assessment checklist was adapted from ISO 56002:2019, the latest version of the ISO 56002 standard. It has been designed to help you to understand the key focus areas of this standard and identify immediate gaps in your present system. |
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創新管理系統自我評估檢查表
這份自我評估檢查表是根據最新的 ISO 56002:2019 標準改編而成。它旨在幫助你了解標準中的重點領域，並幫助分辨與你目前系統中有何差距。 |
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Customer Service Excellence (CSE) Booklet
The launch of this new standard by the Cabinet Office on heralds the beginning of a new era in Government thinking and the promotion of Customer Service Excellence. |
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Control Viral Contaminants with Effective Testing
In this paper we look at the three principal and complementary approaches for the detection of viral contaminants in biologic-based medicines, and the identification of their origins, with our primary focus on the testing of source materials and products. |
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CDISC Library Try-out: From Implementation to Evaluation of the API
In this paper, we will explain the tool and the API calls in more detail and share our thoughts and findings on the use of CDISC Library within the tool. |
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Understanding Maximum Residue Limits For Pesticides in Food
We examine the best ways to manage pesticide residue risk in food and feed products destined for the EU, US, China and Japan. |
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Biosafety & Safety by Design: Identifying Adventitious Agents in Cell & Gene Therapy Production
In this document we look at cell and gene therapies (CGTs), an important growth sector for the biopharmaceutical industry. |
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Cell Substrate Characterization: Genetic Stability & Identity Testing at SGS
Learn about genetic stability and identity testing, key requirements for regulatory approval of therapeutic biological products produced using a cell bank system. |
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Transmission Electron Microscopy: Applications in Biosafety Testing
This white paper looks at the role Transmission Electron Microscopy (TEM) plays in biological sciences and in the assessment of biological safety, particularly in virology. |