Quality, Compliance & Regulatory - software & AI news

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

Showing 92 results
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Aug 20, 2026

Therap Services Introduces PDF Translation for General Event Reports to Support Multilingual Human Services Providers

TORRINGTON, Conn., Aug. 20, 2026 /PRNewswire/ -- Therap Services, the national leader in HIPAA-compliant electronic documentation solutions for organizations in Long-Term Services and Supports (LTSS), Home and Community-Based Services (HCBS), and other human services industries, has introduced a PDF translation feature for General Event Reports (GER). Available via the "Display Printable (PDF)" option, this update enables providers to easily translate printable event records into multiple langua
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Aug 20, 2026

Net Health Launches Chart Audit in Optima Unity, Extending Native AI From Documentation to Compliance Review

Chart Audit joins Optima Unity's native ambient documentation to create a single connected workflow from capturing the encounter to compliance review and clinician approvalPITTSBURGH, Aug. 20, 2026 /PRNewswire/ -- Net Health, an AI-native specialty platform serving clinicians across the care continuum, today announced Chart Audit, a new capability embedded in its Optima Unity EMR. Chart Audit reviews completed rehab therapy documentation against configurable compliance criteria before a clinicia
A minimalist illustration of a test tube filled with liquid against a dark background, representing life sciences compliance.

Aug 16, 2026

Compliance Group launches AI agents for life sciences compliance

Compliance Group has introduced a suite of AI agents aimed at enhancing compliance and quality workflows in the life sciences sector. These agents, named APQR, ATR, and VERA, leverage the CLAiRE platform to automate essential tasks and minimize manual labor.The integration of AI in life sciences is crucial as organizations seek to improve efficiency while ensuring adherence to regulatory standards. The CLAiRE platform, developed over three years, is built to manage the complexities of AI in regu
A minimalist illustration of a clipboard with a checkmark representing compliance in life sciences.

Aug 15, 2026

Compliance Group launches AI agents for life sciences compliance

Compliance Group has introduced a suite of AI agents tailored for the life sciences sector, aimed at enhancing compliance and quality workflows.The newly launched portfolio features three AI agents: APQR (Annual Product Quality Review), ATR (Audit Trail Review), and VERA (Validation Documentation). These agents leverage the CLAiRE platform, specifically designed for regulated industries, to automate various compliance-related tasks, thus significantly reducing the manual workload typically assoc
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
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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