method validation - Blogging About What's Possible - Part 2

Recent posts

Get Empowered: Method Validation | Tip #190, Validation Protocols: Setting up the Repeatability Test in Empower

By September 9, 2020
Empower

In this week’s Empower tip, we will continue our discussion on Validation Protocols and learn how to set up the Repeatability Test.

Categories: Empower Tips
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Get Empowered: Method Validation | Tip #189, Validation Protocols: Creating Default Strings in Empower

By September 2, 2020
Empower

A Default String is text that you can create in advance and then select from a list when you are required to provide a reason for creating and/or modifying something in Empower, such as a method. This week, we’ll continue our discussion on Validation Protocols and learn how to create Default Strings.

Categories: Empower Tips
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Get Empowered: Method Validation | Tip #188, Creating a Validation Protocol in Empower

By August 26, 2020
Empower

A Validation Protocol defines the tests to be run, the data to be acquired for each test, and the acceptance criteria for each test. In this week’s tip, we will discuss creating validation protocols in Empower.

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Get Empowered: Method Validation | Tip #187, Using the Method Validation Manager Option in Empower

By August 19, 2020
Empower

Every compliant laboratory must conduct validation studies to show that analytical methods generate accurate and reliable data. The Method Validation Manager (MVM) option for Empower organizes and streamlines the entire method validation process, from start to finish.

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Method Lifecycle Management Survey Reveals Barriers and Enthusiasm for Change

By January 23, 2019

Waters recently surveyed 100 method developers from innovator and generic pharmaceutical companies to better understand their existing challenges and views on Method Lifecycle Management (MLCM). We’ll share with you the top questions and findings from our survey results.

Categories: General, Pharmaceutical
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Tof-HRMS: Rescuing Low-Exposure Bioanalysis Applications from Chemical Noise

By April 18, 2016

The drug development process requires pharmacokinetic (PK) analysis to be performed as part of safety and efficacy studies in both preclinical species and human subjects. For high-sensitivity bioanalysis, liquid chromatography (LC) coupled to a triple… Read more >

Categories: Pharmaceutical, Technologies
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Mass detection and mAb QC: How a cost-effective and robust peptide mapping method confirms CDR peptides – and can be validated

By March 15, 2016

The quality issues of biopharmaceutical therapeutics are definitely different from chemical drugs because of the increased complexity of manufacturing processes and complexity of the biologic molecules themselves. There is an increasing need for detailed product… Read more >

Categories: Pharmaceutical, Technologies
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Increasing Efficiency of Method Validation with Waters Empower 3 Method Validation Manager (MVM)

By November 12, 2014

Empower® 3 Method Validation Manager (MVM) allows you to perform chromatographic method validation, from protocol planning through final reporting, in one application. Recently, we sponsored a webinar showing ways you can streamline your workflow throughout… Read more >

Categories: Pharmaceutical, Technologies
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Webinar discusses new purity method, 40X increase in productivity

By October 30, 2014

Webinar: QbD Development of a Purity Method Chromicent GmbH (Berlin, Germany) managing directors Alexander Schmidt and Mijo Stanic are experts in the development and validation of analytical methods according to the latest quality-by-design approaches. The… Read more >

Categories: Pharmaceutical
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