Quality, Compliance & Regulatory - software & AI news

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

Showing 92 results
A flat illustration of a microbial plate in a lab setting, symbolizing quality control in pharmaceuticals.

Jun 23, 2026

Clever Culture Systems: AI-driven plate assessment transforms pharma QC, unlocking scalable growth and recurring revenue

Clever Culture Systems is leveraging AI to enhance microbial quality control in pharmaceutical manufacturing, addressing significant inefficiencies and compliance issues.The company's APAS Independence system automates the assessment of microbial plates, providing a scalable solution that meets the high-throughput demands of the industry. This innovation not only streamlines quality control processes but also attracts major pharmaceutical clients, contributing to robust recurring revenue streams
Audit checklist on a desk in a quality assurance office

Jun 22, 2026

Piramal Pharma Solutions Highlights Strong Performance Across More Than 200 Customer Audits

Piramal Pharma Solutions (PPS) has recently reported significant achievements in customer audits and regulatory approvals, marking a pivotal year for the company. Over the past fiscal year, PPS completed more than 200 customer audits and secured over 70 approvals from various regulatory bodies globally, highlighting its commitment to quality and operational excellence.This accomplishment is rooted in PPS's comprehensive quality strategy, which emphasizes sustained compliance and continuous impro
Close-up of medical device packaging with new labeling symbols on a wooden table

Jun 18, 2026

Euro Roundup: Commission gives medtech companies 5 years to adapt to symbols standard

The European Commission has introduced a five-year transition period for medical device manufacturers to adapt to new harmonized standards, particularly regarding labeling symbols.Recently, the Commission revised standards affecting medical devices and diagnostics, specifically EN ISO 15223-1:2021, which dictates the symbols for conveying information on medical devices and their packaging. A key change is the replacement of “EC REP” with “EU REP” to denote “authorized representative.” This trans

Jun 18, 2026

EU draft guidelines sharpen high-risk AI classification for medtech and digital health

The European Commission has released draft guidelines aimed at clarifying the classification of high-risk AI systems within the medtech and digital health sectors. These guidelines are particularly significant for AI technologies that utilize physiological signals, such as gait analysis or ECG readings, to assess patient health, categorizing them as high-risk under the biometric use case.The draft guidelines, which are open for consultation until July 23, do not impose new obligations but provid
Quality control checklist in a manufacturing workspace

Jun 16, 2026

Catalent Debuts AI Tool for Quality Management

Catalent Inc. has introduced Qai, an innovative AI tool aimed at enhancing quality management processes within its operations.The launch of Qai marks a significant step for Catalent, a global contract development and manufacturing organization (CDMO), as it integrates AI into its quality management systems. This enterprise-level solution is designed to improve processes related to deviations and complaints by utilizing Catalent’s extensive data for quicker analysis and effective root cause ident
Minimalist illustration of smart glasses and VR headset

Jun 15, 2026

AutoVRse raises $2.4M from Singularity AMC and Lumikai to scale AI transformation for global Pharma and MedTech

AutoVRse, an emerging player in the industrial AI transformation sector, has successfully secured $2.4 million in funding, co-led by Singularity AMC and existing investor Lumikai. This funding aims to enhance AI-driven training solutions for the pharmaceutical and MedTech industries.AutoVRse specializes in VR-based training and smart-glasses technology, catering to over 500,000 users across more than 50 enterprise clients globally, including major pharmaceutical companies and medical device manu
Researcher reviewing AI outputs in a regulatory setting

Jun 11, 2026

Euro Roundup: EMA researchers share regulatory research priorities for AI across the lifecycle

Researchers from the European Medicines Agency (EMA) have outlined key regulatory research priorities for artificial intelligence (AI) throughout the lifecycle of medicines, emphasizing the importance of accuracy and reliability in AI tools.The EMA's recent preprint paper is based on a survey involving 273 stakeholders, including regulators, industry professionals, and patients. The findings highlight that ensuring the trustworthiness of AI-generated outputs is paramount, particularly as these o
A validation document on a laboratory table in a dimly lit setting.

Jun 11, 2026

Why Validation is Becoming the Proving Ground for AI in Life Sciences

The integration of AI in life sciences is increasingly focused on computer system validation (CSV), a critical area for ensuring compliance and operational efficiency.Despite the widespread adoption of generative AI across various sectors, its tangible business impact remains limited, particularly in the highly regulated life sciences industry. A McKinsey study reveals that while 80% of companies employ generative AI in some capacity, only 40% report a significant impact on earnings before inter
A minimalist illustration of a pill representing pharmaceutical workflows.

Jun 7, 2026

Collate Raises $95 Million Series A To Expand AI Platform For Regulated Life Sciences Workflows

Collate has successfully secured $95 million in a Series A funding round to enhance its AI platform tailored for regulated workflows in the life sciences sector.The investment, led by prominent firms including Redpoint Ventures and Y Combinator, aims to bolster Collate's mission of providing reliable, patient-centric AI solutions for pharmaceutical and life sciences organizations. Founded by CEO Surbhi Sarna, Collate specializes in GxP-compliant software that automates and optimizes workflows wi
A pill bottle and regulatory documents in a dimly lit office

Jun 5, 2026

Pharma compliance adapts to AI and regulation

The landscape of pharmaceutical compliance is undergoing significant transformation as industry leaders adapt to rapid regulatory changes and emerging technologies.During a recent webinar hosted by the Pharmaceutical Compliance Congress, experts highlighted the mounting challenges compliance teams face in an evolving environment. Tim Stow, global head of ethics and compliance at Galderma, noted the dual pressures of adapting to new regulations while managing traditional compliance responsibiliti
Flat illustration of an in vitro diagnostic device and a regulatory document

Jun 5, 2026

Euro Roundup: MedTech Europe welcomes IVDR proposals, calls for strengthening of some changes

MedTech Europe has expressed strong support for proposed changes to the In Vitro Diagnostic Regulation (IVDR), advocating for enhancements in specific areas to optimize regulatory processes.The trade group categorized the proposed IVDR changes into “welcome” and “strengthen” categories, indicating a positive reception overall. A key highlight is the European Commission's initiative for proportionate oversight of low-risk devices, which MedTech Europe views as a necessary adjustment to current re
Silhouette of a document with a checkmark representing regulatory compliance

Jun 2, 2026

Pharma in Focus: The Regulatory Issues Everyone is Talking About

The increasing scrutiny of artificial intelligence (AI) by the FDA is prompting life science companies to enhance their regulatory compliance and quality oversight for AI tools in manufacturing. The inaugural session of "Pharma in Focus: The Regulatory Issues Everyone is Talking About" will delve into these challenges, centering around a case study of the FDA Warning Letter issued to Purolea, which highlights critical regulatory expectations.During this session, experts will discuss how the FDA'