Quality, Compliance & Regulatory - software & AI news

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

Showing 124 results
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Sep 3, 2026

TraceLink and Omnicell Integrate DSCSA Compliance Solution into Hospital Pharmacy Operations

Integration brings serialized product verification and traceability directly into medication receiving workflows, intended to enable more efficient pharmacy operations without separate compliance processes.BOSTON, Sept. 3, 2026 /PRNewswire/ -- TraceLink, the world's largest Agentic Business Network for the life sciences and healthcare supply chain, today announced an integration between its Drug Supply Chain Security Act (DSCSA) compliance solution and the pharmacy inventory management systems o
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Sep 2, 2026

Codoxo Named a Winner in 2026 Fierce AI Innovation Awards

AI-powered Point Zero Payment Integrity recognized for helping health plans prevent payment errors before claims are created.DULUTH, Ga., Sept. 2, 2026 /PRNewswire/ -- Codoxo, the leading provider of AI and generative AI-powered healthcare payment integrity solutions, today announced that its Point Zero Payment Integrity solution has been named the winner in the "AI Innovation in Regulatory & Compliance" category of the 2026 Fierce AI Innovation Awards.Selected following a rigorous review by
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Sep 2, 2026

Systech Launches TraceIQ, Helping Transform Pharmaceutical Traceability from Compliance to Operational Intelligence

DOWNERS GROVE, Ill., Sept. 2, 2026 /PRNewswire/ -- Systech, part of Markem-Imaje and Dover and a leading provider of pharmaceutical serialization and traceability solutions, today announced the launch of Systech TraceIQ™, an intelligent and intuitive enterprise traceability platform created for a new operational reality in pharmaceutical supply chains.Backed by Systech's four decades of packaging execution and serialization expertise, TraceIQ combines core compliance capabilities with an operati
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Sep 2, 2026

MD Integrations Partners With LegitScript, Offering Telehealth Brands Expedited Path to Compliant Launch

MD Integrations is partnering with LegitScript as an Enterprise Certification Partner, offering expedited certification packages to virtual care and telehealth brands seeking compliance as a competitive advantage.NEW YORK, Sept. 2, 2026 /PRNewswire/ -- MD Integrations, the only unified telehealth platform built on a nationwide, doctor-only network, announced a partnership with LegitScript. The partnership embeds LegitScript certification directly into MD Integrations' onboarding workflow, giving
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Sep 2, 2026

Eugia Pharmaceuticals Goes Live with ValGenesis to Modernize CSV

SANTA CLARA, Calif.--(BUSINESS WIRE)--ValGenesis, Inc., the leader in enterprise digital validation, announced that Eugia Pharmaceuticals, a global specialty pharmaceutical company, has gone live with ValGenesis to modernize computer system validation (CSV) processes across its sites in India. The deployment will help enhance compliance, improve operational efficiency, and support growth.Hyderabad-based Eugia Pharma, a subsidiary of Aurobindo Pharma, develops and markets complex generics. The co
A vial of medication on a lab bench in a dimly lit pharmaceutical lab.

Sep 1, 2026

TraceIQ Launched to Maximize Pharmaceutical Traceability

Systech has introduced TraceIQ, a new enterprise traceability platform aimed at enhancing the operational efficiency of pharmaceutical and biopharma supply chains.TraceIQ represents a significant advancement from earlier traceability systems, which primarily focused on meeting serialization mandates and ensuring regulatory compliance. According to Sreedhar Patnala, Systech's general manager, while compliance remains crucial, it is not sufficient in today’s complex supply chain landscape. As regu
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Aug 27, 2026

FDA Inspection Data Reveals a New Compliance Blind Spot for Medical Device Makers

As the FDA deploys AI to analyze submissions at scale, the first QMSR inspection cycle shows problems are spreading across entire quality systems, not just single departmentsSALT LAKE CITY, Aug. 27, 2026 /PRNewswire/ -- Newly surfaced inspection data from the first months of the FDA's Quality Management System Regulation (QMSR) shows a tough new reality for life sciences teams: investigators are no longer looking at procedural gaps in isolation. Instead, they're uncovering interconnected problem
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Aug 20, 2026

Berry Street Adds SOC 2 Type II to Its Compliance Program as Payer and Enterprise Partnerships Expand

Independent third-party audit validates the company's controls for security, availability, and confidentiality as it scales nutrition therapy across all 50 statesNEW YORK, Aug. 20, 2026 /PRNewswire/ -- Berry Street, the nutrition therapy platform connecting patients to insurance-covered care from Registered Dietitians, today announced it has achieved SOC 2 Type II certification, meeting a key security requirement for the health plans, health systems, and enterprise partners it serves.Conducted b
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Aug 20, 2026

Therap Services Introduces PDF Translation for General Event Reports to Support Multilingual Human Services Providers

TORRINGTON, Conn., Aug. 20, 2026 /PRNewswire/ -- Therap Services, the national leader in HIPAA-compliant electronic documentation solutions for organizations in Long-Term Services and Supports (LTSS), Home and Community-Based Services (HCBS), and other human services industries, has introduced a PDF translation feature for General Event Reports (GER). Available via the "Display Printable (PDF)" option, this update enables providers to easily translate printable event records into multiple langua
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Aug 20, 2026

Net Health Launches Chart Audit in Optima Unity, Extending Native AI From Documentation to Compliance Review

Chart Audit joins Optima Unity's native ambient documentation to create a single connected workflow from capturing the encounter to compliance review and clinician approvalPITTSBURGH, Aug. 20, 2026 /PRNewswire/ -- Net Health, an AI-native specialty platform serving clinicians across the care continuum, today announced Chart Audit, a new capability embedded in its Optima Unity EMR. Chart Audit reviews completed rehab therapy documentation against configurable compliance criteria before a clinicia
A minimalist illustration of a test tube filled with liquid against a dark background, representing life sciences compliance.

Aug 16, 2026

Compliance Group launches AI agents for life sciences compliance

Compliance Group has introduced a suite of AI agents aimed at enhancing compliance and quality workflows in the life sciences sector. These agents, named APQR, ATR, and VERA, leverage the CLAiRE platform to automate essential tasks and minimize manual labor.The integration of AI in life sciences is crucial as organizations seek to improve efficiency while ensuring adherence to regulatory standards. The CLAiRE platform, developed over three years, is built to manage the complexities of AI in regu
A minimalist illustration of a clipboard with a checkmark representing compliance in life sciences.

Aug 15, 2026

Compliance Group launches AI agents for life sciences compliance

Compliance Group has introduced a suite of AI agents tailored for the life sciences sector, aimed at enhancing compliance and quality workflows.The newly launched portfolio features three AI agents: APQR (Annual Product Quality Review), ATR (Audit Trail Review), and VERA (Validation Documentation). These agents leverage the CLAiRE platform, specifically designed for regulated industries, to automate various compliance-related tasks, thus significantly reducing the manual workload typically assoc