Data Reporting, Compliance and Integrity – Products
Whitepaper
Data Integrity and Compliance Solutions for Drug Manufacturers
This whitepaper reviews the data integrity and computer system validation (CSV) regulatory landscape in the US and EU, identifies industry trends and challenges and offers best practices for maintaining compliance.
Product
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Alliance™ iS Bio HPLC System
With the Alliance iS Bio HPLC System, you can reduce unwanted interactions between your samples and the HPLC system, produce faster and more reproducible results, reduce human errors, and reduce training requirements.
Product
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Alliance™ iS HPLC System
Alliance iS HPLC System elevates the QC lab with first-time right results and shortened release cycles through enhanced productivity and asset management, maximized system uptime, and minimized service intervention.
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High-Quality GMP Grade FGF-8b: Efficient Dopaminergic Neuronal Differentiation from iPSCs
Consistent GMP-grade products are crucial as key raw materials for safe and reliable cell manufacturing. We adhere to stringent regulatory guidelines to provide high-quality GMP biomaterials for various cell culture and differentiation.
Product News
Sapio Sciences Introduces Sapio GMP LIMS Offering Unmatched Flexibility for Unique Manufacturing Processes
Sapio Sciences announces key new capabilities to its highly flexible, no/low-code LIMS to support laboratories that must comply with GMP, 21 CFR 11, and EU Annex 11 standards.
Product News
HORIBA Launches New Compact Hematology Analyzers With Combined ESR and CBC/DIFF
Yumizen H550 range expands to affordably introduce new applications and configurable hematology options for small to mid-throughput laboratories.
App Note / Case Study
Transition to Hydrogen Carrier Gas for Nitrosamine Analysis
This application note explores the suitability of hydrogen carrier gas, in comparison to helium, for the analysis of eight nitrosamine impurities found in pharmaceutical products.
Whitepaper
Digital Solutions To Protect Pharmaceutical Data
This whitepaper explores the regulatory environment surrounding data integrity, and what to look for in a laboratory information management system (LIMS) to ensure compliance.
Product News
Products for Sustainable Food Development
AMSBIO offers a range of kits, media and reagents enabling development of food in a way that is not wasteful of our natural resources and is not detrimental to the environment or consumer health.
Product News
Bionova Scientific Announces Plans for New Plasmid DNA GMP Facility
Facility in The Woodlands, Texas to produce critical starting material for cell and gene therapy, DNA/RNA based, and recombinant protein therapeutics in Q1/2025.
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