FDA Modernization Act 2.0: Accelerate Readiness with an Advanced LIMS Solution
In April 2025, clinical research reached a turning point, with advances reshaping both the science and the regulations that guide it. The FDA unveiled its Roadmap to Reducing Animal Testing in Preclinical Safety Studies, offering a phased strategy for integrating non-animal methods into drug development. Around the same time, the NIH announced the launch of […]
Understanding Compliance Regulations in the Life Science Sector Part 1
Compliance with industry regulations is non-negotiable in the fast-paced and highly regulated realm of life sciences. Navigating the intricate web of rules and standards is essential to ensure product and service safety, efficacy, and quality. This blog seeks to unravel the complexities of compliance regulations in the life science sector, providing a comprehensive understanding for […]
What the FDA’s Quality Metrics Reporting Program Means for Your Lab
Quality metrics are utilized throughout the pharmaceutical industry to assure product quality and facilitate continued improvement of drug manufacturing processes. The FDA has also shown a significant interest in quality metrics, as data detailing compliance with quality standards in drug manufacturing helps the FDA establish compliance and inspection policies, predict and potentially mitigate future drug […]
What the New FDA Guidance on Electronic Records and Signatures Means for Clinical Trials
The digital age is upon us. The FDA has acknowledged the increasing use of computerized systems to manage electronic records generated in the production of FDA-regulated products with applicable regulations and several guidance documents that strive to protect public health by securing digital data integrity. In March of 1997, the FDA released 21 CFR Part […]
Strategies for Surviving an FDA Audit
As part of its mission to ensure public safety, the FDA inspects manufacturers or processors of FDA-regulated products to verify that they comply with relevant regulations. The FDA also inspects facilities that conduct clinical trials with humans and laboratories that conduct studies with animals or microorganisms when these studies are used to apply for FDA […]
Trends in FDA Data Integrity 483s and Warning Letters for Pharmaceutical Companies
The manufacture of pharmaceutical drugs is a highly complex process that involves advanced scientific analysis and instrumentation at all stages of production and storage. In order to guarantee the safety and efficacy of both human and veterinary drugs, the FDA strives to verify data integrity in all cGMP records used to document and guide the […]