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
The Differences Between Cell Therapy and Gene Therapy: A Comprehensive Guide
Cell and gene therapy are similar fields of biomedical research aimed at treating genetic diseases and are often combined in treatment.
Immunotherapy Research and Development Studies: A Breakthrough in Cancer Treatment
This article delves into the latest advancements in immunotherapy research and development, its various types, and how it's shaping the future of oncology and beyond.
Anthrax Bacteria Testing: Essential Procedures for Early Detection and Public Health Safety
Anthrax bacteria testing is crucial to detect, prevent, and manage outbreaks, ensuring public health safety
Toxicology Testing: Ensuring Safety and Compliance in Products and Environments
Discover how toxicology testing protects human health, supports regulatory approval, and promotes innovation across various industries
Immunogenicity Testing of Biologics: Ensuring Safety and Efficacy in Biopharmaceuticals
The rise of biologic therapies has revolutionized treatment options across various medical...
CLIA and its Role in Ensuring Quality in Clinical Laboratories
CLIA inspections and evaluations assess a laboratory’s performance, record-keeping practices, and quality assurance protocols
Residual DNA Testing: Understanding Host Cell DNA Analysis in Biopharmaceuticals
By detecting and quantifying trace amounts of host cell DNA, manufacturers can ensure the safety, quality, and compliance of their products.
A Laboratory Guide to Toxicity Testing
Using a combination of in vitro, in vivo, and in silico methods, researchers and manufacturers can obtain comprehensive toxicity data that informs product development, risk assessment, and regulatory compliance.
Cancer Research – NYU Creates Molecule to Fight Cancer Cells
Need a laboratory for cancer research? Today, the US National Science Foundation issued a Press...
Medical Device Sterilization Validation Testing
As the medical device industry continues to evolve and innovate, the importance of sterilization validation will remain a key factor in ensuring the safety and success of medical products.
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