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Validation Life Cycle Management Speeds Auditing, Facilitates Regulatory Inspections

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If you’ve ever enjoyed the experience of an audit or inspection, then you know it’s about as much fun as having your wisdom teeth extracted.

Repair or Replace an Asset?

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Deciding whether to repair or replace an asset can be difficult. That’s why maintenance and reliability managers perform an analysis to determine whether it’s more economical to repair a failing asset or replace it with a new one.

Is Statistical Process Control Still Relevant?

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Today’s manufacturing systems have become more automated, data-driven, and sophisticated than ever before.

How to Structure a Clinical Investigation Report Summary

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If you’re conducting a clinical investigation of a medical device in a European Union member state, you will be required to submit a clinical investigation report (CIR) along with a summary of the CIR to that member state.

Aligning Incident Management With ISO 45001 Requirements

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The number of ISO 45001 certificates is growing fast, jumping 54% from 2020 to 2021, according to the ISO Survey.

When Assignable Cause Masquerades as Common Cause

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The difference between common (or random) cause and special (or assignable) cause variation is the foundation of statistical process control (SPC).

Managing Systemic Risks in Tech

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Last month, the heads of seven major American AI companies emerged from the White House with an agreement on 

EHS Incident Management and Root Cause Analysis

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Ethical Considerations for Successful ERP Implementation

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In this age of rapid technological innovation, the introduction of sophisticated technologies in various industries has raised complex ethical dilemmas.

Build Your Culture of Quality With These Four Foundational Principles of Quality 4.0

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Let’s start with a definition of Industry 4.0, keeping in mind that we’re rapidly approaching Industry 5.0. Industry 4.0 is an era marked by enhanced digitization and the increased connectivity of smart technologies.

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