Fitness for the intended use of analytical equipment and systems

[ ARTICLE ] Analytical Instrument Qualification with Data Integrity in Mind Heather Longden, Senior Marketing Manager, Pharmaceutical Regulatory Compliance Waters Corporation, Milford, MA, USA It is critical to understand the data integrity implications regarding analytical instrument qualification. OVERVIEW Analytical Instrument…

[ ARTICLE ] Analytical Instrument Qualification with Data Integrity in Mind Heather Longden, Senior Marketing Manager, Pharmaceutical Regulatory Compliance Waters Corporation, Milford, MA, USA It is critical to understand the data integrity implications regarding analytical instrument qualification. OVERVIEW Analytical Instrument…

You talk, we understand – The way out of the tower of Babel The problem We live in a “global village” but we are all different and we use many different languages to communicate. Even when people speak the same…

Interlaboratory comparisons other than proficiency testing Introduction The international standard ISO/IEC 17025 [1] clause 7.7.2 with regards to ensuring the validity of results, requires a laboratory to participate in proficiency testing (PT) and/or to participate in interlaboratory comparisons (ILCs) other…