Quality, Compliance & Regulatory - software & AI news

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

Showing 124 results
A compliance document on a lab bench with a notebook in a life sciences lab.

Nov 5, 2026

Gxp Compliance Support Is Coming To The Public Cloud. That’s Good For Life Sciences

The emergence of public-cloud ERP solutions for GxP compliance is poised to transform the life sciences industry significantly.Recent developments indicate that public cloud-based GxP compliance systems will not only alleviate the financial burdens associated with compliance but also enhance product quality and patient safety. These systems are particularly beneficial for smaller life sciences companies that have historically struggled with expensive, patchwork compliance solutions. By integrati
A syringe and vial in a dimly lit lab setting, emphasizing human oversight in AI applications.

Nov 4, 2026

What Europe's Draft Annex 22 Actually Asks Of Human Oversight Of AI

Europe's draft Annex 22 outlines critical guidelines for human oversight in AI applications within the pharmaceutical sector, emphasizing the need for rigorous human review processes in GMP operations.The draft, under consultation until October 2025, specifically addresses AI models that affect patient safety and product quality. It categorically states that certain AI types, like generative models, should not be employed in critical applications. Instead, it mandates that qualified personnel ov
A medical device prototype on a lab bench in a clinical setting.

Nov 2, 2026

PCCP Without MLOps Is Just a Promise to FDA

The FDA's Predetermined Change Control Plan (PCCP) offers a pathway for medical device manufacturers to iterate on AI models post-clearance, yet few are taking advantage due to a lack of necessary MLOps infrastructure.Recent findings indicate that only a small fraction of AI-enabled devices authorized by the FDA between 2023 and 2025 utilized the PCCP framework, which allows for pre-approved model updates. The underlying issue is not regulatory reluctance but rather the manufacturers' inability
A minimalist gear icon representing validation processes in pharmaceuticals.

Oct 28, 2026

Crossing the Digital Validation Chasm

Researchers from the University of Limerick highlight a significant gap in digital validation processes within the pharmaceutical manufacturing sector, proposing a risk-based workflow to bridge this divide.The study points out that the disconnect between traditional validation methods and advanced digital strategies is not primarily a regulatory issue. Instead, it stems from the challenge of effectively integrating risk-based validation principles into everyday engineering practices. Dermot McMo
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Oct 28, 2026

Medical Component Specialists Appoints Pedro Moreira to Multisite Quality Manager III as Costa Rica Facility Begins Operation

Medical Component Specialists (MCS), a leading provider of medical components, proudly announces the appointment of Pedro Moreira as Global Multisite Quality Manager III. BELLINGHAM, MA / ACCESS Newswire / October 27, 2026 / Medical Component Specialists (MCS), a leading provider of medical components, proudly announces the appointment of Pedro Moreira as Global Multisite Quality Manager III. Moreira's appointment reinforces the company's commitment to world-class supply chain reliability and ma
A validation document on a lab bench in a diagnostics laboratory.

Oct 27, 2026

Leading U.S. Diagnostics Laboratory Selects Valkit.ai to Modernize Validation

A prominent U.S. diagnostics laboratory has chosen Valkit.ai to transition from traditional document-heavy validation processes to a more streamlined, risk-based digital assurance system.With revenues exceeding $700 million, the laboratory faces significant pressure to deliver rapid and accurate results while maintaining compliance with regulatory standards. Historically, validation in the diagnostics sector has relied heavily on paper documents, which often leads to inefficiencies and challenge
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Oct 26, 2026

The Regulation Of New Medical Tech Is Becoming A Lifelong Process

The Regulation Of New Medical Tech Is Becoming A Lifelong ProcessFor most of the history of medical deviceregulation, approval has been treated as a single moment: a device is tested,assessed and authorised, and the questions that follow are largely aboutwhether it keeps performing as it did on the day it was approved. Artificialintelligence as a medical device (AIaMD) does not fit that model well. Softwarecan be updated, retrained or deployed in settings its developers did not fullyanticipate,
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Oct 23, 2026

TraceLink Launches Track & Trace Lakehouse to Expand Compliance and Analytical Access to End-to-End Serialized Events

Built on the OPUS Lakehouse, the new capability gives life sciences and healthcare customers SQL-based access to serialized event data, with integrated reporting and analytics through OPUS Reports and DashboardsBOSTON, Oct. 23, 2026 /PRNewswire/ -- TraceLink, the world's largest Agentic Business Network, today announced the launch of Track & Trace Lakehouse, a new capability that gives life sciences and healthcare companies analytical access to end-to-end serialized product events. Built on
A prescription pad and pill bottle cap on a pharmacy counter in low light.

Oct 22, 2026

FDA recognizes standalone software's role in improving drug therapy

The FDA has taken a significant step in recognizing the role of standalone software in enhancing drug therapy through new guidance for prescription drug use-related software (PDURS).This guidance establishes a framework for the integration of digital health tools, such as dosage reminders and health coaching applications, into the drug prescribing process. By requiring that these standalone apps be included on prescribing labels when they demonstrate clinical benefits or are essential for safe m
A minimalist representation of a digital notepad and pen symbolizing AI in healthcare.

Oct 22, 2026

8 popular AI scribes may need medical device regulation: TGA

The Therapeutic Goods Administration (TGA) has identified that eight out of twelve AI-powered digital scribes may require regulation as medical devices, despite suppliers not classifying them as such.This review, published on October 16, underscores a significant gap in the awareness of medical device regulations among suppliers as AI scribes evolve from simple documentation tools to systems that can influence patient care through recommendations. The TGA has issued guidance to clarify the regul
Flat design illustration of interconnected nodes symbolizing data flow and compliance in MedTech.

Oct 16, 2026

How AI Is Connecting MedTech’s Data Without Compromising Compliance

AI is transforming the MedTech landscape by enhancing data connectivity and compliance without overwhelming existing systems.MedTech manufacturers are facing increasing regulatory demands and market pressures, compelling them to explore new revenue streams while ensuring compliance throughout a product's lifecycle. Traditional quality management (QMS) and product lifecycle management (PLM) systems have often been isolated, leading to data fragmentation across various business functions such as r
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Oct 14, 2026

Veeva Summit Platinum Sponsor Spotline to Showcase AI-Powered Validation Automation

Live demonstrations of V-Assure AI and V-Assist will highlight validation automation and contextual user guidance within Veeva VaultBOSTON, Oct. 14, 2026 /PRNewswire/ -- Spotline Inc., a provider of AI, automation, validation, and integration solutions for life sciences, today announced that it is a Platinum Sponsor at the 2026 Veeva R&D and Quality Summit in Boston, October 20–21. Spotline will demonstrate V-Assure AI, its AI-powered validation automation platform, along with V-Assist, its