Easing the demands of a compliant pharmaceutical laboratory

May 4, 2023 | Blogs, Pharma, QTRAP / Triple Quad, ZenoTOF | 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.

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Standard peaks are noisy

I am Using Sciex Qtrap 4500 for quantification of nitrosamines (NDMA&NDBA). I am facing issue with higher baseline intensity. When developed the method in APCI the basline was at about 5e4. but now even after cleaning the source (i.e. Changed capillary to new, Curtain plate & Corona needle cleaning, given blank injection overnight ), my base line decreased from 1e6 to 4 e5, but settled at 4 e5 from past 24 hours. can you suggest me how decrease my baseline intensity further to below 1e5. My standard peaks are like noise now.

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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.



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