Stage 3 verification: Establishing and maintaining a state of control In pharmaceutical quality control (QC), consistency should mean more than an analyst ending a shift relieved that the results were repeatable and there were no obvious failures. It should mean having enough confidence in the process, the controls, and the data to know that those…
Audit readiness isn’t a last-minute activity triggered by validation or inspection. It’s established much earlier, at method design, through the scientific understanding, risk-based control, and documentation needed to demonstrate that a method is fit for purpose and capable of performing consistently over time. If those elements aren’t built in from the outset, gaps are likely…
With the ever-present threat of cyberattacks, safeguarding laboratory data has become a top priority for scientists across the globe. Many labs are accelerating digitalization efforts, but that could expose their data to greater risks. The Increase in Lab Digitalization: Effects on Cybersecurity As it turns out, the increase in digitalization, particularly the shift to the…
The collaboration between Waters and AWS has enhanced the waters_connect System Monitoring tool, revolutionizing laboratory productivity. This cloud-based platform provides secure, compliant access to chromatography lab information, allowing users to coordinate work, address system errors, and make informed decisions from anywhere, anytime.
Recent developments in techniques for rapid and efficient oligonucleotide synthesis and molecular biology technology have expanded the market for manufacturers and service providers in the field. Liquid chromatography coupled with mass spectrometry (LC-MS) workflows play a critically important role.
The new waters_connect for quantitation software, including the new MS Quan app – is designed to allow labs to increase productivity and harness the full potential of their lab.
Combining BioAccord, our most capable MS detection platform, with ACQUITY Premier UPLC, our highest performance LC system, to demonstrate superior performance.
Avoiding the pitfalls of data quality and integrity in the Pharma QC laboratory while running routine analyses is an ongoing challenge. Regulatory violations are frequently a result of a lack of complete data, suspect data, and improper audit trails. A recent report from Deloitte stated that data integrity violations account for over 70% of the…
Learn how to bring increased confidence to your sample preparation workflows using automation, smart lab tools and electronic documentation from Waters. This blog post was revised in September 2023 to include the most up-to-date information.
OneLab, cloud-native laboratory software, allows members to securely design and implement sample preparation protocols for lab analysts. Learn more by reading this post, which was revised in September 2023 to include the most up-to-date information.
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 testing for decades. It has proven to be particularly important for quality control and manufacturing support laboratories in the pharmaceutical…
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 are legitimate, and which are an indication of poor quality? Which are harmless and which are dangerous? Which are expected…