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Featured

Mohammad Ramezanalizadeh / Unsplash

A Guide to 21 CFR Part 11 and Annex 11 Compliant Signatures
Lexi Sharkov
We’d be willing to bet your key collaborators aren’t all in the same building. Your team members, contract partners, clients, and suppliers are likely scattered across the globe. That makes collecting physical, “wet ink” signatures nearly impossible and turns digital approvals into a daily necessity. But how you collect those electronic signatures matters, especially for GxP-regulated…

Risk Management

QMS Implementation in 90 Days

Ninety days to implementation vs. 12 to 18 months with traditional systems: That’s not just an incremental improvement—it’s a complete reimagining of what’s possible in life sciences quality management.

In the highly regulated life sciences industry, quality management system (QMS)…

How to Conduct a Root Cause Analysis

When an issue arises, it’s important to take quick action. Whether that means launching a software patch, pulling a batch, or halting the use of a reagent, it’s critical to tackle the immediate problem.

But just as critical as “How do we fix this?” is “How do we make sure this…

AI-Ready Manufacturing: Data, Quality, and the Digital Future

Today, manufacturing is largely shaped by supply chain volatility, complex labor dynamics, and—like most global industries—the rise of AI. Adopting AI technologies on the shop floor can help manufacturers minimize operational costs, mitigate risk, and optimize processes, which drives efficiency…

Exascale Simulations Underpin Quake-Resistant Infrastructure Design

Simulations still can’t predict precisely when an earthquake will happen. Still, with the incredible processing power of modern exascale supercomputers, they can now predict how they will happen and how much damage they will likely cause. 

Imagine a colossal earthquake strikes…

Lessons From GAMP 5

Software selection, implementation, and ongoing maintenance are critical stages in the life cycle of biomedical software systems such as asset and calibration management platforms. Yet few industry resources provide detailed, practical guidance for managing these processes effectively.

…

Preparing Your Quality System for AI-Enabled Asset Management

What if your quality system could detect and initiate corrective actions for equipment deviations before they affect product quality?

It’s a compelling vision—and one that’s becoming increasingly achievable through AI-enabled automation. But let’s be clear: We’re not there yet.…

more articles
CAISI Evaluation of DeepSeek AI Models Finds Shortcomings and Risks
Chinese developer lags behind US in performance, cost, security, and adoption
NIBS Releases Report for Central Building Information Modeling Transportation Library
Landmark road map for creating BIM standards across varied infrastructure
By Light Achieves CMMC Level 2 Certification Beyond Its SOC
Few organizations reach this milestone
NewTek Constructs Radiation-Resistant LVDTs in Multiple Temperature Ranges
Supporting next-generation nuclear power applications
Bluestreak Launches Laboratory Information Management System
Bringing clarity, control, and compliance to laboratory operations
NIST Guidelines Can Help Organizations Detect Face Photo Morphs
Deterring identity fraud
TÜV Rheinland North America Expands Accreditation
Boosts global compliance capabilities
NIST Finalizes ‘Lightweight Cryptography’ Standard to Protect Small Devices
Four related algorithms are ready for use to protect data created and transmitted by the internet of things and other electronics
Manufacturers Show Resilience Amid Economic Uncertainty, But Challenges Persist
Wipfli’s 2025 manufacturing benchmarking study
Critical Manufacturing Acquires Convanit
Convanit will advance AI-powered image analytics in smart manufacturing
Building the AI Future
Construction’s digital lag risks derailing global data-center boom
more news

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