A significant market opportunity lies in providing comprehensive training on technical documentation for medical device manufacturing, focusing on DHF, DMR, and DHR. This ensures regulatory compliance ...

Korrapati's implementation work is complemented by industry engagement, including presenting on CSA implementation and roadblocks at professional venues ...

The "GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries (Jan 28th - Jan 29th, 2026)" training has been added to ResearchAndMarkets.com's offering. This Auditing for GMP ...

BioPharma Consulting Group today announced the launch of a new digital transformation advisory framework designed to ...

The "Digital Validation and Cloud Assurance: Validating SaaS, PaaS and Automated Pipelines under CSA - Modular Course for Practitioners (Jan 21st - Jan 26th, 2026)" training has been added to ...

The U.S. Food and Drug Administration (FDA) announced on Tuesday that it will limit regulatory oversight of wearable devices and software designed to support healthy lifestyles, issuing new guidance ...

The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including certain wearable devices) and the other related to clinical decision ...

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. Mario Aguilar covers technology ...

This is read by an automated voice. Please report any issues or inconsistencies here. Stanford computer science graduates are discovering their degrees no longer guarantee jobs as AI coding tools now ...

“Risk is a lens, not a leash. Once teams see what truly threatens patients and processes, the busywork falls away, and quality gets sharper,” said Sindhuri Korrapati, a senior supervisor for software ...

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.