21 CFR Part 11 Compliance: Electronic Records Management
Ensure seamless 21 CFR Part 11 compliance for electronic records and signatures in pharma labs. Master FDA regulations, computer validation, and data integrity.
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Biotechnology & Life Science Products Articles
Sterility Testing: Ensuring Safety in Critical Industries
Ensuring product sterility is vital for patient safety, regulatory compliance, and quality assurance across pharmaceutical, medical device, and biotech sector
FDA and CMS: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They Are Made
In recent years, the FDA has identified several concerns with laboratory developed tests ( LFTs)
CDRH Announces Intent to Initiate the Reclassification Process for Most High Risk IVDs
FOR IMMEDIATE RELEASEJanuary 31, 2024 The following is attributed to Jeff Shuren, M.D., J.D.,...
A Comprehensive Guide to AAMI Medical Device Testing
Learn more about the rigorous assessment processes defined by AAMI standards to ensure that medical devices meet the necessary safety, efficacy, and performance benchmarks
ASK THE LAB EXPERT: The Complex Nature of Drug Formulation: Stories from a Formulation Lab
Drug formulation is and continues to be challenging. Every product is different. Every drug behaves differently based on its physicochemical properties. Understanding those properties through preformulation and in vitro permeability testing is important in designing an appropriate dosage form.
Therapeutic Goods Administration (TGA): Ensuring the Safety and Quality of Therapeutic Products in Australia
The Therapeutic Goods Administration, or TGA is a division of the Australian Government Department of Health. The TGA is responsible for regulating therapeutic goods, like prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products.
The Importance of Pharmaceutical ADME Studies
Pharmaceutical ADME studies are designed to investigate how a chemical is processed by an organism.
The Vital Role of IgY Testing on Dried Egg Yolk for Dietary Supplements
We received this request yesterday at Contract Laboratories! Diet supplements are always a popular industry, but egg yolks are a unique testing medium! let's spotlight this test request and dig a little deeper into IgY assays.
CAM Assay: A Key Tool for Angiogenesis and Cancer Research
The CAM assay, or Chorioallantoic Membrane assay, is a technique in biological research that involves the using a developing chicken embryo for experimental purposes.
The Importance of Testing Canine Hip and Joint Supplements
Just like for human supplements, the role that laboratories play in testing dog hip and joint supplements is indispensable
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