Quality, Compliance & Regulatory - software & AI news

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

Showing 124 results
A checkmark over a clipboard representing compliance and validation in life sciences.

May 21, 2026

Zifo to Showcase AI-Driven Validation and Compliance Innovations at CSV & CSA University Europe 2026 in Dublin

Zifo is set to showcase its advancements in AI-driven validation and compliance at the upcoming CSV & CSA University Europe 2026, emphasizing the industry's need for AI-ready compliance ecosystems.Taking place on June 2-3, 2026, in Dublin, Ireland, this conference will focus on the intersection of artificial intelligence, compliance, and digital transformation in the life sciences sector. As a Gold Sponsor, Zifo will contribute to discussions on Computer Software Assurance (CSA) and Computer Sys
A barcode scanner scanning a packaged pharmaceutical product in a warehouse setting.

May 21, 2026

AI-Driven Traceability Platforms Reshape Indian Pharma’s Push for Global Compliance and Supply Chain Visibility

AI technology is transforming the Indian pharmaceutical landscape, particularly in enhancing compliance and supply chain transparency.Annora Pharma, a subsidiary of Hetero Group, is collaborating with AltiusHub to upgrade its drug traceability system through AI-driven serialization and regulatory compliance technologies. This initiative aims to boost serialization efficiency by 45% and provide real-time visibility throughout its global supply chain, catering to major markets such as the US, EU,
A flat silhouette of a regulatory document with a checkmark, symbolizing compliance in life sciences.

May 20, 2026

Ennov Secures Growth Investment From Bregal Sagemount and Ardian to Expand AI-Driven Life Sciences Platform

Ennov has secured a significant growth investment led by Bregal Sagemount, with participation from Ardian, to enhance its AI-driven regulatory and compliance software platform for the life sciences sector.The Paris-based company specializes in software that integrates regulatory, quality, clinical, and pharmacovigilance functions for pharmaceutical and healthcare organizations. The new funding will facilitate advancements in AI product development, support international expansion, and enable bro
A regulatory document and pen on a desk in a dimly lit office setting.

May 20, 2026

Ennov Secures Major Investment to Fuel AI in Life Sciences Compliance

Ennov has announced a significant investment aimed at enhancing its AI capabilities in the life sciences compliance sector, led by Bregal Sagemount and supported by Ardian.The funding will enable Ennov to accelerate its development of AI-driven solutions designed to streamline regulatory, quality, and clinical data management for pharmaceutical and healthcare organizations. This investment aligns with a broader industry trend toward integrated software platforms that can replace outdated, discon
A compliance document and pen on a desk in a dimly lit office

May 20, 2026

Ennov Announces Strategic Growth Investment from Bregal Sagemount and Ardian

Ennov, a leading provider of regulatory and clinical software solutions, has secured a significant growth investment from Bregal Sagemount and Ardian. This funding aims to enhance the company's focus on AI innovation and expand its global market presence.Headquartered in Paris, Ennov offers a comprehensive compliance platform that integrates various domains such as Regulatory, Quality, Clinical, and Pharmacovigilance. Designed to streamline complex regulatory processes, Ennov's software replaces
A minimalist illustration of a robotic arm and an audit trail icon in a dark palette.

May 19, 2026

Opentrons Launches Compliance Ready Software for the Opentrons Flex® at SLAS Europe 2026

Opentrons Labworks has unveiled its Compliance Ready Software (Opentrons CRS) for the Opentrons Flex® robotic platform, designed to facilitate regulatory compliance in laboratory settings. This software aligns with U.S. FDA Title 21 CFR Part 11 standards, offering essential features like authentication, signed audit trails, and role-based access, all while maintaining a significantly lower total cost of ownership compared to traditional GxP systems.The introduction of Opentrons CRS comes at a ti
Minimalist illustration of a drug package

May 18, 2026

Annora Pharma expands partnership with AltiusHub to strengthen AI-driven serialization

Annora Pharma has intensified its partnership with AltiusHub to implement an AI-driven serialization platform aimed at enhancing operational efficiency and regulatory compliance in its global supply chain.The collaboration seeks to boost serialization efficiency by 45%, facilitating better tracking and compliance across major export markets, including the US, EU, GCC, LATAM, and ASEAN. Annora Pharma aims to achieve full real-time visibility of its serialized drug products within three months, en
A flat design of a serialized product with a barcode on a solid background.

May 18, 2026

Annora Pharma Expands Collaboration with AI-Native Traceability Platform AltiusHub to Strengthen Global Drug Traceability

Annora Pharma has intensified its partnership with AltiusHub to enhance drug traceability globally through an AI-driven platform.The collaboration focuses on deploying AltiusHub’s advanced serialization and track-and-trace technology across Annora Pharma’s export operations. This initiative is projected to boost serialization efficiency by as much as 45% and improve visibility throughout the supply chain, particularly in key markets such as the US, EU, GCC, LATAM, and ASEAN regions. Annora Pharm
A minimalist illustration of a document with a checkmark, symbolizing approval in medical review processes.

May 18, 2026

Medical, Legal, and Regulatory (MLR) Review Software

The global market for Medical, Legal, and Regulatory (MLR) Review Software is experiencing significant growth, projected to expand from $13.1 billion in 2025 to $27.1 billion by 2032, reflecting a compound annual growth rate (CAGR) of 10.9%.This software is increasingly essential for organizations in the pharmaceutical and healthcare sectors, helping them navigate complex regulatory requirements efficiently. By centralizing the review and approval processes for promotional materials, clinical do
A stack of regulatory documents and a compliance checklist on a desk in a dimly lit office.

May 18, 2026

Medical, Legal, and Regulatory (MLR) Review Software Business Report 2026: A $27.1 Billion Market by 2032 from $13.1 Billion in 2025 - Rising Demand for Streamlined Compliance in Pharma and Biotech

The Medical, Legal, and Regulatory (MLR) Review Software market is poised for significant growth, with projections indicating a rise from $13.1 billion in 2025 to $27.1 billion by 2032, reflecting a compound annual growth rate (CAGR) of 10.9%.This growth is largely attributed to the increasing complexity of regulatory requirements and the pressing need for organizations in the pharmaceutical and biotechnology sectors to streamline compliance processes. MLR review software serves as a vital resou
A regulatory stamp with a checkmark symbolizing oversight in AI medical devices.

May 15, 2026

FDA Rejects Proposal to Ease Oversight of AI Medical Devices

The FDA has opted not to relax its oversight of certain AI medical devices, emphasizing the importance of patient safety amid rapid technological advancements.The U.S. Food and Drug Administration (FDA) recently rejected a proposal from Harrison.ai, an Australian health AI firm, which sought to ease premarket review requirements for specific AI-enabled diagnostic tools. The company argued that developers with prior approvals and robust post-market monitoring should face fewer regulatory hurdles.
A syringe and medical chart in a clinical setting

May 14, 2026

MedTech Abandons Legacy Tools for AI-Powered Development Platforms

The MedTech industry is undergoing a significant transformation as companies increasingly shift from outdated legacy systems to advanced AI-driven platforms, enhancing innovation and compliance while improving patient outcomes.Recent developments highlight a pivotal trend in the medical technology sector, where organizations are moving away from traditional, fragmented software solutions. Enlil, Inc., an AI-powered traceability platform, recently reported a record first quarter in 2026, securing