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.

ADC analytics FAQs: Answering the most common questions about ADC characterization

Antibody-drug conjugates (ADCs) have emerged as one of the fastest-growing classes of biotherapeutics, combining the targeting specificity of monoclonal antibodies with the potency of cytotoxic payloads. However, this unique architecture also introduces significant analytical complexity. From drug-to-antibody ratio (DAR) distributions and charge variants to conjugation sites and structural modifications, ADCs present multiple, interconnected sources of heterogeneity that must be understood to ensure product quality and performance.

Sterile but toxic: Cereulide detection in food matrices

In a recent webinar, Ming Gao, Ph.D., Senior Research Chemist at Mérieux NutriSciences, explored the growing challenge of cereulide contamination in food products and the analytical strategies needed to detect this heat-stable toxin at trace levels. The session examined how LC-MS/MS can help laboratories overcome the limitations of traditional microbiological screening and meet emerging regulatory requirements.

How SCIEX Now empowers mass spec users to work with more control, clarity and confidence

In this interview, Andy Wilcox, Senior Market Development Manager, Aftermarket and Software, speaks with Susanna Baqué, Senior Director of Global Customer Experience, about how SCIEX Now gives customers one connected digital workspace to manage instruments, reduce time spent searching for information, resolve issues faster and keep their laboratory running more efficiently and with greater confidence.

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

Pin It on Pinterest

Share This

Share this post with your network