Regulatory Compliance Solutions
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SCIEX M5 MicroLC System
9/6/2023
See More with Microflow LC-MS
The M5 MicroLC system is the perfect balance of sensitivity and robustness—more sensitive than traditional analytical flow LC, and more flexible and more robust than nanoflow LC — giving you the potential to optimize your critical workflows, today and into the future.
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Compliance Program For EU Annex 1 Container Closure Requirements
Discover a program designed to comply with Annex 1 CCI requirements, focusing on vials, syringes, and cartridges. This holistic, science-based approach generates robust data throughout the product life cycle.
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Cleanrooms And Equipment For Cell Therapy Drug Manufacturing
6/9/2023
Delivering on the promise of cell and gene therapy through Germfree products and services.
Germfree Laboratories offer advanced modular and mobile facilities, equipment, and comprehensive services for cell therapy manufacturing. Acknowledging the complexity of personalized treatments, Germfree’s adaptable solutions optimize production processes, ensuring aseptic conditions, scalability, and compliance with regulatory standards. This enables efficient, high-quality cell therapy delivery to patients in need, supporting manufacturers in overcoming industry challenges.
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Product Lifecycle Excellence Platform
8/27/2021
Our platform is simple yet comprehensive. It’s scalable and secure. It combines our proven digital process automation, unmatched quality data management, and analytics into a single, natively connected platform. One that gives you tools to make quality a priority throughout your organization.
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Meet Regulatory Guidelines In GMP/GLP Labs With SoftMax Pro GxP Software
6/21/2023
Become compliant with FDA 21 CFR Part 11 and EudraLex Annex 11 software validation
SoftMax® Pro 7.2 GxP Software is the latest, most secure software to achieve full FDA 21 CFR Part 11 and EudraLex Annex 11 compliance with streamlined workflows to ensure data integrity. Every step is optimized to simplify analysis and reporting to support our microplate readers.
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Pharmaceutical Automation And Information Technology Services
12/21/2020
As a company that specializes in troubleshooting complex systems and equipment, especially in regulated industries, we have gained expertise in Automation & Information Technology (IT) systems. These systems are the foundation of the manufacturing equipment and processes we have been commissioning and qualifying for over 20 years. Our teams work to deliver fully functional and compliant, mechanical and automated systems to our clients. Our expertise extends from specification, through implementation and startup, and into true process optimization.
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Document Control Software For Life Sciences
8/23/2021
Digital document control systems introduce automation into your processes. A digital solution is not only more efficient, it also makes it easier to keep up on regulatory changes and maintain compliance.
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MasterControl Change Controlâ„¢
3/20/2023
Explore a line of validation products and services addressing different levels of validation needs based on individual risk assessment. They're designed to allow “continuous validation” for FDA-regulated companies.
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Transformative Cell Line Development Workflow ClonePix 2 Mammalian Colony Picker
6/21/2023
A transformative cell line development workflow with automated clone screening and optional monoclonality assurance on day 0*
The ClonePix® 2 Mammalian Colony Picker​ is a complete solution for the automated screening and objective selection of high-value clones across diverse cell types.
The ClonePix® 2 Mammalian Colony Picker is a fully automated system for selecting high-value clones used in antibody discovery and cell line development. Screen more clones in less time with monoclonal verification on day zero, then screen and identify for highest producers in weeks, not months.
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SpectraMax M Series Microplate Readers
6/15/2023
Configurable readers with triple-mode cuvette ports, validation tools, and compliance software.
The SpectraMax® M Series Multi-Mode Microplate Readers measure UV and visible absorbance, fluorescence, luminescence, fluorescence polarization, TRF and HTRF.