Why Validation In Life Sciences Can No Longer Be A One-Time Event

Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.
News Medical

The Role of Process Validation in Ensuring Consistent Drug Quality

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...
Convenience Store News

FDA Streamlines PMTA Process With Improved Web-Based Options

CTP Portal Next Generation also accepts Substantial Equivalence submissions. Step-by-step instructions on completing the forms; A more user-friendly interface that helps guide applicants through the ...
KXAN

InstantGMP Modernizes Software Validation with FDA Computer Software Assurance-Aligned Approach

InstantGMP categorizes software functions into low, moderate, and high process-risk groups. Low-risk features, such as equipment, room, deviation, and CAPA logs, primarily collect or tabulate data.
GEN

Machine Learning for Process Validation

Validating drug production processes need not be a headache, according to AI researchers who say machine learning (ML) could be a single answer to biopharma’s multivariate problem. The FDA defines ...
Medical Xpress

Almost half of FDA-approved AI medical devices are not trained on real patient data, research reveals

Artificial intelligence (AI) has practically limitless applications in health care, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor ...
Seeking Alpha

Tivic Health Enters GMP Manufacturing Validation Agreement with Scorpius BioManufacturing in Preparation for FDA Submission

FREMONT, Calif.--(BUSINESS WIRE)-- Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today it has entered a definitive agreement with Scorpius BioManufacturing ...
EurekAlert!

Almost half of FDA-approved AI medical devices are not trained on real patient data

Artificial intelligence (AI) has practically limitless applications in healthcare, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor ...