Stage 3: Continued Method Performance Verification

Practicing continuous improvement ensures that the method operates as expected in routine use, which is an important part of lifecycle management. Tracking performance data can reveal areas of concern, and lead to corrective or preventative action. Instrument qualification and system suitability testing are also integral to ongoing procedure performance.

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Continued Method Performance Verification in Depth

Blogs / Articles
What is Changing Analytical Method Transfer Today? Part 3: Methods Across Borders
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A scientist at a major global pharmaceutical company estimated that an analytical method could see 50, 60, or even up to 100 transfers in its lifetime. Increasingly, such transfers will take place across geographic borders. Check out this insight-filled blog to learn more.

Blogs / Articles
What’s Changing Analytical Method Transfer Today? Part 1

Your analytical method may well have a long and useful life ahead of it. After all, many pharmaceutical companies have methods dating as far back as the 1970s or 1980s. A new analytical testing landscape is taking shape, and it’s having a big effect on how we develop, transfer, and update methods. Data quality and business efficiency are both at stake. Are you ready? This blog will bring you up to speed on the changes ahead.

Blogs / Articles
What’s Changing Analytical Method Transfer Today? Part 2: Organizations

As the average cost and specialization needed to bring a drug to market exceeds the $2 billion mark, the number of partner organizations will increase as well. If you’re an analytical or QC scientist, get ready for more method transfers between organizations. Check out this new blog series to learn more.

Pharmaceutical QA/QC Infographic

The need for efficient, predictable, and connected QC lab operations has never been greater. Check out this infographic to gain insights about the cost of ownership vs. cost of analysis, building data integrity, and more.

Publications & Whitepapers
Dwell Volume and Extra-Column Volume: What Are They and How Do They Impact Method Transfer

Method transfer or method scaling across different LC instrument platforms can be affected by both dwell volume and extra-column dispersion. Each characteristic will have a different effect on the chromatographic separation. This white paper reviews strategies to minimize that impact. These recommendations follow the USP <621> guidelines.

Quality Control reference materials

QCRMs enables you to evaluate and benchmark your system, ensuring repeatable performance each and every time your system is run.

Columns Calculator Version 2.0

The Waters Columns Calculator enables you to scale a method by calculating operating parameters that give equivalent chromatographic performance. Use the Columns Calculator to quickly define methods that you can test further in the laboratory.