Quality, Compliance & Regulatory - software & AI news

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

Showing 73 results
A compliance document and pen on a desk in a dimly lit office

May 8, 2026

Modicus Prime: $8 Million Raised To Expand AI Compliance Infrastructure For Pharma

Modicus Prime has successfully secured $8 million in funding, bolstering its efforts to enhance AI compliance infrastructure within the pharmaceutical sector.The recent funding round, which included a significant $4.5 million investment from Frist Cressey Ventures, alongside contributions from Silverton Partners and Oncology Ventures, comes on the heels of the company's successful deployment of its Trustworthy AI Compliance Software. This software is aimed at pharmaceutical companies and other r
A clipboard with quality metrics in a pharmaceutical office setting.

May 6, 2026

New MasterControl Survey: Pharma Quality Teams Struggle to Get Employees Engaged With Quality Systems, a Hurdle for AI Ambitions

A recent survey by MasterControl highlights a significant concern within the pharmaceutical industry: while leaders are optimistic about AI's potential, they struggle with employee engagement in quality systems, which is crucial for AI implementation.The survey, involving 300 quality and manufacturing leaders in the life sciences sector, revealed that 94% of pharmaceutical quality leaders see poor employee adoption of quality systems as a major challenge. This issue raises questions about the fe
A flat illustration of an audit checklist representing compliance in pharma.

May 6, 2026

Modicus Prime Raises $8M to Enable AI Audit Readiness Across Pharma

Modicus Prime has successfully secured an additional $4.5 million in funding, bringing its total to $8 million, aimed at enhancing AI compliance in the pharmaceutical sector.Based in Austin, Texas, Modicus Prime has developed the Trustworthy AI Compliance Software, designed to ensure that AI applications in regulated environments meet audit requirements. This software integrates seamlessly with existing pharmaceutical tech stacks and quality management systems, serving as a centralized complianc
A flat silhouette of a regulatory document with a checkmark, symbolizing approval in MedTech.

May 5, 2026

Rimsys Launches the Regulatory Execution Engine for MedTech

Rimsys has unveiled its Spring 2026 release, a transformative platform designed to enhance regulatory operations for MedTech companies. This new system shifts focus from merely storing regulatory data to executing regulatory strategies effectively.The Spring 2026 platform introduces a suite of features aimed at improving the speed and efficiency of regulatory teams. Key components include AI-driven regulatory monitoring, which provides timely updates on regulations across over 90 countries, and
A compliance checklist on a desk in a dimly lit office

May 5, 2026

i-GENTIC AI Expands GENIE to Enforce Full FDA Compliance Lifecycle for Life Sciences

i-GENTIC AI has enhanced its GENIE platform to streamline compliance with FDA regulations throughout the product approval lifecycle in the life sciences sector.GENIE, a pioneering intelligence engine, translates complex regulatory requirements into machine-executable logic, facilitating real-time compliance. This innovation addresses a significant challenge faced by biopharma and medtech companies: ensuring consistency across vast amounts of documentation during the approval process. Zahra Timsa
Silhouette of a regulatory team member with a clipboard against a minimal wet lab outline

May 4, 2026

New Pistoia Alliance poll finds regulatory teams benefit most from AI, but just 1% see value in the wet lab

A recent poll by the Pistoia Alliance highlights the uneven impact of AI in life sciences, emphasizing that regulatory teams are reaping the most benefits, while wet lab applications remain largely undervalued.The data, gathered at the Alliance's annual European conference in London, indicates that while nearly 30% of life sciences organizations have adopted enterprise-wide AI platforms, a significant 69% lack metrics to evaluate AI's effectiveness in reducing costs or timelines in drug R&D. Onl
A laboratory vial with a drug compound in a dimly lit lab setting.

May 4, 2026

Agentic AI poised to reshape pharma operations beyond pilot-stage adoption: Duraisamy Rajan Palani, Founder & CEO, Archimedis Digital

In a recent interview, Duraisamy Rajan Palani, Founder and CEO of Archimedis Digital, delves into the transformative potential of Agentic AI in the pharmaceutical sector, emphasizing its pivotal role in enhancing operational workflows.Agentic AI represents a significant advancement over traditional automation methods, particularly suited for the highly regulated and documentation-heavy nature of the life sciences industry. Its applications are notably impactful in scientific workflows, such as d
Prescription bottle for compounded medication on a pharmacy shelf

May 1, 2026

MEDVi AI Telehealth Case Raises Compliance Questions

The emergence of MEDVi, an AI-powered telehealth startup specializing in weight-loss treatments, has sparked regulatory scrutiny and raised significant compliance concerns within the digital health sector. As the company experiences rapid growth, generating substantial revenue with minimal staffing, its marketing practices and operational model are under examination for potential patient safety risks.Recently, the U.S. Food and Drug Administration (FDA) issued a warning letter to MEDVi, citing m
A minimalist illustration of a petri dish with a microbe, symbolizing biotechnology.

Apr 30, 2026

CPHI Americas 2026 returns to Philadelphia with AI, regulatory focus

CPHI Americas 2026 is set to return to Philadelphia from June 2-4, focusing on regulatory changes, AI integration, and advancements in biotechnology.This annual conference serves as a vital networking platform for professionals across the pharmaceutical supply chain, including manufacturers, biotech firms, and service providers. Attendees will engage in discussions aimed at addressing key challenges facing the industry, with a particular emphasis on evolving regulatory frameworks and the impact
A minimalist representation of a digital validation checklist with a tick mark.

Apr 29, 2026

Top European CDMO Taps Kneat for Digital Validation Overhaul

A leading European Contract Development and Manufacturing Organization (CDMO) is partnering with Kneat.com to enhance its digital validation processes, marking a significant shift towards digital transformation in the life sciences sector.This collaboration will see the CDMO adopt Kneat’s Gx platform to digitize equipment validation across its extensive network of production sites. This initiative is part of a broader strategy to improve operational efficiency, scalability, and regulatory compli
A regulatory document on a lab bench with a microscope in the background.

Apr 28, 2026

Accenture Ventures Invests in Iridius to Scale Compliant-by-Design AI for Life Sciences and Pharmaceuticals

Accenture Ventures has strategically invested in Iridius, a company focused on compliant-by-design AI solutions tailored for regulated industries such as life sciences and pharmaceuticals.This partnership aims to enhance compliance workflows throughout the life sciences value chain, addressing critical areas like regulatory submissions and clinical operations. Iridius employs a knowledge engine that translates complex regulatory standards into machine-readable logic, effectively embedding compli
A checkmark on a clipboard symbolizing compliance in workflows.

Apr 25, 2026

Iridius Raises $8.6M Seed Round to Build Compliance-by-Design AI Platform for Regulated Enterprise Workflows

Iridius has successfully secured $8.6 million in seed funding to develop an innovative AI platform that integrates compliance directly into enterprise workflows, addressing a critical barrier for regulated industries.The funding round, led by Chalfen Ventures and supported by notable investors like Osage Venture Partners and Accenture Ventures, reflects a strong belief in the team and the substantial market potential. Iridius aims to transform compliance from a hindrance into a strategic advanta