Quality, Compliance & Regulatory - software & AI news

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

Showing 92 results
A minimalist illustration of a pill bottle and a pill on a solid background.

May 26, 2026

LSPedia Secures Investment to Fuel AI-Driven Pharma Supply Chain

LSPedia has secured a significant investment aimed at enhancing its AI-driven solutions for pharmaceutical supply chains, marking a shift from mere compliance to a more predictive and automated model that addresses critical industry challenges.Recently, LSPedia, a prominent player in pharmaceutical supply chain software, received a strategic growth investment from Bregal Sagemount. This funding is intended to help LSPedia evolve its operations beyond regulatory compliance, focusing instead on cr
A clipboard with regulatory documents on a wooden desk in a clinical office

May 26, 2026

What’s changing in AI regulation for drug development

Recent regulatory developments are shifting the landscape for AI in drug development, as organizations pivot from experimentation to establishing robust AI systems that meet regulatory standards.On January 14, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) released joint guiding principles aimed at defining good AI practices in drug development. These principles serve as a reference for integrating AI into regulated processes, emphasizing the need for risk-base
Cold storage unit with pharmaceutical products in a dimly lit warehouse

May 26, 2026

How Digital Strategies Transform Pharma Supply Chains in 2026

The pharmaceutical supply chain is evolving rapidly, driven by the need for agility and compliance amid increasing operational complexities. As margins tighten, companies must adopt digital strategies to enhance performance and mitigate risks associated with regulatory pressures and geopolitical challenges.The article outlines how pharmaceutical leaders are leveraging digital transformation to optimize supply chain efficiency. Emphasizing Eliyahu Goldratt’s Theory of Constraints (TOC), it highli
A petri dish with bacterial culture in a dim lab setting

May 22, 2026

Ennov: Strategic Growth Investment From Bregal Sagemount And Ardian To Expand AI-Driven Life Sciences Software Platform

Ennov, a key player in the life sciences software sector, has secured a strategic investment from Bregal Sagemount and Ardian to enhance its AI-driven solutions. This funding aims to accelerate the company's growth by expanding its product offerings and global market reach.Headquartered in Paris, Ennov specializes in regulatory, quality, and clinical software solutions, providing a comprehensive compliance platform for life sciences organizations. This platform streamlines various operational ar
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