Quality, Compliance & Regulatory - software & AI news

Daily news on software, AI, and companies shaping quality, compliance & regulatory.

Showing 92 results
A laboratory workspace with labeling materials scattered on a table, illustrating the process of artwork and labeling in life sciences.

Jun 2, 2026

AI and Automation in Artwork & Labelling for Life Sciences: Advancing Quality and Efficiency, Upcoming Webinar Hosted by Xtalks

A forthcoming webinar will delve into how AI and automation are transforming labeling and artwork processes in the life sciences sector, aiming to enhance quality and efficiency.The event will explore the persistent issue of labeling errors, a significant contributor to pharmaceutical recalls. As regulatory demands intensify, the focus is shifting from merely identifying errors to preventing them earlier in the workflow. Featured speakers will discuss implementing AI-driven quality checks that o
A close-up of an AI algorithm on transparent film in a dimly lit lab setting.

Jun 2, 2026

If Your AI Can’t Explain Itself, Can FDA Authorize It?

Algorithmic transparency is becoming crucial for FDA evaluations of AI/ML medical devices, as manufacturers face challenges in explaining their models despite high performance metrics.As AI-powered diagnostic tools gain traction, the FDA is emphasizing the importance of understanding how these algorithms function rather than solely focusing on performance metrics like sensitivity. Manufacturers are increasingly receiving deficiency letters not for underperformance, but for failing to elucidate t
Vapor cloud in a pharmaceutical manufacturing facility

Jun 1, 2026

Is Veeva Systems (VEEV) Quietly Rewiring Pharma Workflows Into a Deeper Enterprise Cloud Moat?

Veeva Systems is making significant strides in integrating its cloud and AI solutions into the workflows of life sciences companies, as evidenced by recent partnerships with Kindeva Drug Delivery, Merck KGaA, and Teva Pharmaceuticals. These collaborations aim to enhance quality and commercial operations across various sectors, including manufacturing and research.The recent adoption of Veeva Quality Cloud by Kindeva exemplifies how Veeva is solidifying its role in the life sciences ecosystem. Th
A desk with regulatory documents and a medical device in a dimly lit office.

May 30, 2026

Tata Elxsi and OpenAna Unveil Anatel™, An AI‑Native Platform Redefining Regulatory‑Ready MedTech Software Engineering

Tata Elxsi and OpenAna have introduced AnaTel™, an innovative AI-native platform aimed at transforming regulatory-ready software engineering in the MedTech sector.This platform was unveiled at DeviceTalks Boston 2026 and is designed to streamline compliance processes while significantly reducing the development timelines for Software as a Medical Device (SaMD). By leveraging autonomous AI agents, AnaTel™ can cut development cycles from eight weeks to just 72 hours, potentially increasing product
An open research notebook with a pen in a dimly lit office setting.

May 30, 2026

Simplification, standardisation & AI-enabled industry: Veeva R&D and Quality Summit 2026

The Veeva R&D and Quality Summit 2026 in Copenhagen focused on advancing the life sciences industry through standardization and AI integration.This year's summit, held on May 28-29, emphasized the vision of creating a unified industry cloud aimed at improving patient outcomes. Veeva, a leader in providing cloud solutions for life sciences, serves a diverse clientele, including major pharmaceutical firms and emerging biotech companies. Senior VP Rik Van Mol highlighted the importance of collabora
Flat design of a cloud and gear representing Veeva's cloud platform and quality management tools.

May 28, 2026

Why Veeva Systems (VEEV) Stock Is Up Today

Veeva Systems’ stock saw a notable increase of 3.8% following the announcement of Kindeva's adoption of its Veeva Quality Cloud platform, aimed at modernizing manufacturing operations.Kindeva, a global contract development and manufacturing organization, plans to unify its global sites on Veeva's cloud platform, leveraging its quality management and training tools. This strategic move not only enhances Kindeva’s operational efficiency but also signifies a substantial win for Veeva, underscoring
A medical device prototype showcased at a tech expo, surrounded by blurred attendees.

May 28, 2026

Tata Elxsi Launches AnaTel™, an AI-Native Software Development Platform for Healthcare and Med-Tech Powered by OpenAna

Tata Elxsi has unveiled AnaTel™, an innovative AI-native software development platform tailored for the healthcare and medical technology sectors, in collaboration with OpenAna.Launched at DeviceTalks Boston 2026, AnaTel™ aims to tackle increasing operational challenges faced by medtech software teams, particularly in light of stringent regulatory requirements for AI-enabled device software. With the FDA and European guidelines demanding rigorous lifecycle documentation and validation, AnaTel™ i
Abstract representation of an AI agent in healthcare

May 28, 2026

Tata Elxsi launches AnaTel AI platform for healthcare

Tata Elxsi has introduced AnaTel, a cutting-edge AI development platform tailored for the healthcare sector, aiming to significantly expedite software development timelines.This platform, co-created with OpenAna, is designed to meet increasing regulatory demands by integrating autonomous AI agents into engineering workflows. Unveiled at DeviceTalks Boston 2026, AnaTel can potentially cut development cycles by up to 60%, addressing the operational hurdles that medtech software teams face, particu
A medical notebook and pen on a wooden table in a clinical workspace

May 27, 2026

Tata Elxsi launches AnaTel, an AI native software development platform

Tata Elxsi has introduced AnaTel, a pioneering AI-native software development platform tailored for healthcare and medical technology sectors, in collaboration with OpenAna. This launch occurred at DeviceTalks Boston 2026, showcasing advancements in AI-driven MedTech engineering and compliance.The healthcare and medtech industries are currently grappling with increasing regulatory demands, particularly concerning AI-enabled device software. Upcoming guidance from the FDA and Europe's MDCG emphas
A heart model in a clinical setting with a medical chart in the background.

May 27, 2026

Cardiac AI Diagnostics Clears China Regulatory Gate Via Lishman Global As Edison Award, Northern California Deployment, And Indigenous Partnership Stack Validation

VentriPoint Diagnostics Ltd. is making significant strides in the cardiac AI diagnostics space, recently achieving multiple validation milestones that enhance its market positioning in China and beyond.In a notable development, VentriPoint's VMS+™ 4.0 system has been submitted for regulatory approval to China's National Medical Products Administration (NMPA) via its partner, Lishman Global. This submission benefits from the NMPA's "green channel," which expedites the approval process for innovat
Minimalist illustration of a medical device

May 27, 2026

Tata Elxsi Launches ViTel for AI-Driven Material Intelligence in MedTech

Tata Elxsi has unveiled ViTel™, an innovative AI-driven material intelligence solution tailored for the medical device sector, highlighting its commitment to enhancing MedTech engineering and compliance.Introduced at DeviceTalks Boston 2026, ViTel is a collaborative effort with Viridium AI, aimed at addressing the complexities faced by medical device manufacturers. These challenges include stringent compliance requirements, sourcing risks, and the management of fragmented data across various ent
A compliance document and pen on a wooden desk in a dimly lit office.

May 26, 2026

Beyond Digital: The Future of AI-Powered Life Sciences Compliance

The life sciences sector is undergoing a transformative shift towards AI-powered compliance, emphasizing efficiency while navigating regulatory challenges.The article discusses the increasing importance of artificial intelligence in enhancing compliance within the life sciences industry. As organizations evolve from basic digital systems to more intelligent operations, the integration of AI is seen as a strategic necessity. ValGenesis, a leader in digital validation, is organizing the ValConnect