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Understanding current CFR 21.11 and data integrity requirements

8 August 2018 | By SUEZ

The US FDA and European Commission have defined regulations relating to the submission of electronic records in lieu of paper documents, for submission, inspection, and archiving purposes. When ageing analytical equipment is to be replaced 21CFR Part 11 and EU Annex 11 are also topics of discussion. Common questions from…

Quality assessment of biologics: higher order structure analysis using NMR

27 July 2018 | By Bruker

The webinar describes how 2D NMR can offer protein biochemists unprecedented analytical precision. By assigning just one spectrum, users can obtain a unique fingerprint of a protein at an atomistic resolution. This non-destructive technique can also be combined with other complimentary techniques to gain even further insights into sample quality.…

Tecan’s Spark® reader aiding research into rare skin disease

5 July 2018 | By

Researchers at the University Hospital of Salzburg's EB House Austria are using a Tecan Spark® multimode reader to investigate epidermolysis bullosa (EB), a rare inherited disease that causes the skin to become ‘as fragile as a butterfly’s wings’, blistering in response to friction or trauma...