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Accessibility Compliance in Medical Device Software: A Strategic Imperative

Perficient: Drug Development

Accessibility compliance in medical device software is more than a regulatory checkbox; it’s a strategic necessity that impacts user safety, market reach, and brand reputation. Human Factors Engineering : The FDA expects manufacturers to incorporate human factors engineering principles into the design and development of medical devices.

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Comprehensive guide for web and ADA compliance in shopify website

Perficient: Drug Development

ADA compliance ensures that your e-commerce site is usable by people with visual, auditory, and other impairments. Who needs to follow ADA compliance standards? Let’s have a deeper look at ADA compliance and what it means for eCommerce stores. Look for themes that explicitly mention ADA compliance. What is WCAG?

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Lilly Announces Leadership Transitions in Manufacturing and Ethics and Compliance Organizations

The Pharma Data

Eli Lilly and Company (NYSE: LLY) today announced the upcoming retirement of two executive committee members and the naming of their successors in the company’s manufacturing operations and ethics and compliance organizations. Hernandez and Weems will report to David A. Prior to joining Lilly in 2005, Hernandez worked for Pfizer.

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AI in drug discovery: faster, smarter, better

Drug Target Review

Zylberberg shares a notable success story involving a CAR-T therapy developer – a type of cell therapy that uses genetically engineered T-cells to fight cancer. In manufacturing, AI-driven automation can optimise workflows, reduce errors, and ensure compliance with regulatory standards.

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Drug-induced long QT syndrome: Concept and non-clinical models for predicting the onset of drug-induced torsade de pointes in patients in compliance with ICH E14/S7B guidance [Minireview]

ASPET

Those models along with the surrogate markers can play important roles in quantifying TdP risk of new compounds, impacting late-phase clinical design and regulatory decision-making, and preventing adverse events on post-marketing clinical use.

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Case Study: How to Ensure Safety While Manufacturing Highly Potent APIs

Alta Sciences

Engineering and Administrative Controls: The cornerstone of safe HPAPI manufacturing lies in strict controls and the use of personal protective equipment (PPE). Engineering controls, such as airlocks and pressure-controlled rooms, further minimized the risk of airborne contamination and cross-contamination.

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The paradox of data in precision medicine

Drug Target Review

A new, single, centralised source of truth must be created, with security, governance and compliance as top priorities, serving as a trusted research environment. Ideally, this platform should be SOC 2 Type 2 and HIPAA-compliant and undergo constant penetration tests by third-party auditors.

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