Easing the demands of a compliant pharmaceutical laboratory

May 4, 2023 | Blogs, Pharma, QTRAP / Triple Quad, ZenoTOF 7600 system | 0 comments

Readtime: 3 minutes

At SCIEX, we are proud to provide analytical systems to the pharmaceutical industry. We work hard to understand the demands of analytical work and the processes required to develop and manufacture drugs.

While the performance of an analytical instrument is an obvious requirement, we also understand that developing a robust method is just the beginning. In one of the most highly regulated industries, it is no easy task to run a laboratory and satisfy all the relevant regulatory bodies around the world.

Much more than a metal box

If we have done our job right, our products should ease the burden of meeting regulatory requirements. SCIEX OS software is compliant-ready with features that support and enable you to be as efficient as possible and reduce the potential for human error.

For example, the user-friendly interface is intuitive, which reduces training time for scientists. Security management controls user access rights to prevent accidental changes to methods, method edits are logged for auditing and only approved users can sign off reports. These features are all designed to make your work life easier.

Meet our team

Our field service engineers and consultants are here for you, from system installation to method development and maintenance visits. You can choose a service level that meets your needs. Options include installation qualification and operational qualification (IQOQ) to ensure your system is always qualified, and that ongoing maintenance is taking place.

The qualification status of your instrument will be maintained because our engineers complete their work using good document practices to ensure you are audit-ready, giving you peace of mind. Read more about how to achieve 21 CFR Part 11 compliance with SCIEX OS software in accordance with Good Laboratory Practice (GLP).

Let’s meet a few members of the SCIEX team and hear how they help customers every day.

Greg Hart

Kimberly Warner

Laura Baker

You are in safe hands. SCIEX has delivered more than 10,000 qualifications and over 1,000 validations without any regulatory findings.

SCIEX is a partner in your laboratory. Learn more by visiting the Small Molecule Therapeutics section of our website.

Understanding PFAS and its impact on U.S. drinking water

In recent years, per- and polyfluoroalkyl substances (PFAS), often referred to as “forever chemicals,” have become a growing topic of interest due to their persistence in the environment and potential health risks. These synthetic compounds have been widely used in various industrial applications and consumer products since the 1940s. PFAS can be found in the air, soil, and water, and studies have shown that most people have detectable levels of PFAS in their bloodstream. One of the main exposure pathways for humans is through drinking water, particularly in communities located near industrial sites, military bases, or areas where firefighting foam has been used.

Selecting an LC-MS system for quantitation of pharmaceutical drug development

We understand you are busy, needing to prioritize running instruments, reporting results and managing your laboratory to meet deadlines. We created a solution guide to explain how SCIEX systems fit in the drug development pipeline to save you time evaluating options.

Nitrosamines: Where are we now?

Nitrosamines are a large group of N-nitroso compounds that share a common functional N-N=O group. They are produced by a chemical reaction between a nitrosating agent and a secondary or tertiary amine. Back in 2018, nitrosamines suddenly found themselves in the spotlight when they were unexpectedly detected in medications for high blood pressure. Since then, they have been found in several other prescription medications, including those for heartburn, acid reflux and diabetes, resulting in manufacturers recalling some common medications.

Posted by

Kirsten Craven is the Senior Global Marketing Manager for Pharma global strategic marketing at SCIEX. In this role, she manages strategic marketing for the pharmaceutical industry. Kirsten spent the first part of her career working in laboratories across multiple industries before moving into product management, and most recently pharma marketing.

Tags


0 Comments

Submit a Comment

Wordpress Social Share Plugin powered by Ultimatelysocial