Quality, Compliance & Regulatory - software & AI news

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

Showing 124 results
A minimalist representation of a compliance document with a checkmark in a dark color scheme.

Aug 15, 2026

Compliance Group launches AI agents for life sciences compliance

Compliance Group has unveiled a suite of AI agents tailored for the life sciences sector, aimed at automating quality and compliance processes to enhance efficiency and reduce manual workloads.The newly introduced AI agents—APQR (Annual Product Quality Review), ATR (Audit Trail Review), and VERA (Validation Documentation)—are built on Compliance Group's CLAiRE platform, specifically designed for regulated industries. This platform has been in development for over three years and ensures governan
Press release cover image

Aug 14, 2026

Vanova Health Enables Independent Physicians to Capture the Full Value of Care Delivered With Arintra's Autonomous Medical Coding

By removing Coding and Charge Entry from the Provider Workflow, the Enablement Company Sees Greater Accuracy, Stronger Compliance, and the Average E/M Level Rising From 3.49 to 3.63VERONA, N.J., Aug. 14, 2026 /PRNewswire/ -- Vanova Health, a physician enablement company serving independent physician practices across New Jersey, today announced that its athenahealth-based providers are now live on Arintra's autonomous medical coding platform, removing coding and charge entry entirely from their d
A regulatory document on a desk in a clinical office setting

Aug 4, 2026

Dassault Systèmes to Acquire ArisGlobal for Life Sciences AI and Compliance Capabilities

Dassault Systèmes has announced its plan to acquire ArisGlobal, a software provider specializing in AI solutions for the life sciences sector, in a deal valued at around $1.8 billion. This acquisition aims to enhance Dassault's offerings in regulatory affairs, pharmacovigilance, and quality management, among other areas, thereby creating a more integrated data environment for managing the entire therapy lifecycle.The acquisition is set to strengthen Dassault Systèmes’ existing life sciences port
A compliance document on a lab bench with a notebook and pens

Jul 27, 2026

Dassault Buys ArisGlobal in Up to $2 Billion AI Software Deal

Dassault Systemes has announced its acquisition of ArisGlobal, a U.S.-based compliance platform for the life sciences sector, in a deal valued at up to $2 billion. This acquisition aims to enhance Dassault's capabilities in supporting drug development and regulatory compliance through AI technologies.The transaction includes an upfront payment of $1.8 billion in cash, with an additional $200 million contingent on ArisGlobal achieving specific AI-related revenue goals. This marks Dassault's first
A vial of medication on a lab bench with compliance documents in the background.

Jul 23, 2026

Tarini Mohapatra: The 1.2 Million Dollar Lesson That Changed Life Sciences Compliance Forever

In the evolving landscape of life sciences, the integration of AI into compliance frameworks is becoming critical for success.Tarini Mohapatra, CEO and Co-Founder of TFives, reflects on a significant learning experience where an AI solution for detecting adverse drug reactions, despite achieving 85% accuracy, faced an 18-month delay due to compliance issues. This situation underscored a fundamental challenge in regulated environments: successful models can become liabilities without proper evide
A minimalist illustration of a pill bottle against a dark background.

Jul 16, 2026

Kallik warns pharma manufacturers against AI ‘compliance timebomb’

Kallik has issued a caution to pharmaceutical manufacturers about the risks associated with deploying AI technologies without a solid data foundation. The company, known for its labeling and artwork management solutions, points out that many in the industry are hastily adopting generative AI and automation to meet increasing regulatory demands and accelerate market entry.This urgency is compounded by skills shortages and evolving global labeling requirements, prompting a surge in investments in
A minimalist illustration of a pill bottle and a regulatory document in a dark color scheme.

Jul 10, 2026

AI, drug shortages & global regulation

Dr. Peter Gough offers a detailed regulatory overview addressing two critical issues in the pharmaceutical sector: artificial intelligence (AI) and drug shortages. He clarifies the current regulatory landscape in the EU, USA, and UK while forecasting future developments in these rapidly evolving areas.Focusing on AI, Dr. Gough emphasizes its vast potential alongside inherent risks, echoing concerns from industry leaders about the necessity for stringent oversight. He highlights the EU as a front
Minimalist illustration of a medical device and AI brain icon

Jul 9, 2026

Getting ready for the EU AI Act? MDIA’s session has you covered

The Malta Digital Innovation Authority (MDIA) is hosting an informative session titled “AI in MedTech: Preparing for the EU AI Act” on July 17, 2026. This hybrid event aims to equip stakeholders, including medical device manufacturers and healthcare innovators, with insights into the implications of the EU AI Act for AI-powered medical devices and digital health solutions.The session is particularly timely as AI's integration into medical technology is becoming essential for diagnostics and pati
A minimalist illustration of a medical device and AI technology.

Jul 7, 2026

MDUFA VI Draft Commitment Letter Includes Faster Pre-Submission Lane, Expanded AI Commitments

The FDA's recent draft commitment letter for MDUFA VI introduces significant changes aimed at enhancing the medical device approval process. Published on July 7, the draft outlines a tiered pre-submission lane designed to expedite the review process for medical devices. This new framework allows for more streamlined interactions between device developers and the FDA, potentially reducing time to market. Additionally, the commitment letter emphasizes an increased focus on digital health technolog
A clipboard with a checkmark representing regulatory compliance in clinical trials.

Jul 3, 2026

VEEV - AI-Powered Veeva Systems Poised for Solid Growth Amid Regulatory Stability

Veeva Systems (NYSE: VEEV) is carving out a significant role in the life sciences sector, leveraging artificial intelligence (AI) to enhance its already robust offerings in clinical trials, regulatory submissions, and drug safety.Veeva stands apart from typical cloud-software companies by embedding its systems deeply within the operational frameworks of pharmaceutical and biotechnology firms. This integration creates substantial switching costs, as changing vendors involves significant risks rel
A vial of pharmaceutical liquid on a lab bench in a quality control lab

Jul 3, 2026

As India expands QR tracking, pharma industry looks to AI for quality

India's recent expansion of QR code tracking in the pharmaceutical sector aims to enhance the authenticity and transparency of life-saving medicines, now including a broader range of products like antimicrobials and anti-cancer drugs. This initiative is part of a "track-and-trace framework" designed to improve supply chain integrity.The government's data indicates a significant increase in drug sample testing, with samples rising from 84,874 in 2020-21 to 116,323 in 2024-25. While the annual det
Flat illustration of a stethoscope in a medical context

Jul 2, 2026

Update: AI-Enabled Medical Devices and IVDs Confirmed as “High-Risk”

The recent agreement on the AI Act confirms that AI-enabled medical devices and in vitro diagnostics (IVDs) are classified as “high-risk.”This classification follows the political consensus reached on the Digital Omnibus on AI, which clarifies that these devices, already regulated under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), will also be subject to the AI Act’s stringent requirements. Specifically, an AI system qualifies as high-risk if it is either a prod