In our current series on Validation Protocols, we reviewed Validation Tests that determined whether the ‘chromatographic method’ is valid. In this tip, we’ll discuss a Validation Test that determines whether the ‘chromatographic system’ is valid.
In this week’s tip, we will continue our discussion on configuring tests for the Validation Protocol and learn how to set up the Accuracy Test.
In this week’s Empower tip, we will continue our discussion on Validation Protocols and learn how to set up the Repeatability Test.
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.
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.
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.
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.
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 >
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 >
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 >