Enhancing performance, mitigating risk, and improving efficiency Today, Waters introduced the Arc HPLC, a modern liquid chromatography system that replicates established test methods while delivering improved performance. HPLC has been a cornerstone of routine analytical… Read more >
In an earlier blog, I discussed the concerns about extraneous peaks that might appear in LC separations. While there can be many sources for peaks unrelated to the test substances, how do you decide which… Read more >
How do data integration and reintegration affect data integrity?
Analytical data can be so much more than a historical point in time documented in a single report. In fact, biopharmaceutical organizations can use LC-MS data to build a continuum of compliance.
What procedures can an analyst use to ensure that a chromatography system is ready to begin analyzing samples, without the fear that the system suitability tests would immediately fail?
For biopharmaceutical organizations working with contract labs, it’s important to consider how data and methods will be transferred and how generated data will be managed so that it meets data integrity and compliance requirements.
In this week’s tip, I thought it would be timely to answer a question I recently received that pertains to data security for chromatography systems: Restricting access to Empower Software and Empower projects.
Analytical methods transfer. Data integrity. A changing and more stringent regulatory landscape. All this, and more, impacts productivity in upstream and downstream biopharmaceutical processes. How is Waters looking to help address development challenges for biologics and biosimilars?
Halting a chromatographic analysis where the system is not performing correctly or when another error is evident in the separation is a valuable and scientific way to avoid creating unusable data that needs to be subsequently invalidated following a defined analytical lab error/result SOP. But what do you do with that orphan data?
Removing the ability for individual users to either delete data or to disable audit trails is expected to be both implemented and validated for data integrity. But when changes are required, what editing tools should be accessible to an analyst?