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How to Prepare for a Virtual Laboratory Audit

Due to the rise of remote work policies stemming from the COVID-19 pandemic, in person laboratory auditing has been nearly impossible over the past year. Reacting to these difficulties, the FDA announced in March of 2020 that they would be scaling...

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Tags: Compliance, audit, fda audit, laboratory industry

The ROI on a Specification Management System: Is It Worth It?

If you’re a packaging or manufacturing professional, you’ve likely experienced the frustration of spending precious time tracking down data. The manual nature of managing specifications using spreadsheets and shared drives has likely caused...

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Tags: specification management, Spec Management, ISO 9001, Compliance

3 Compliance Issues That Can Be Solved by Automation

Maintaining regulatory compliance while making a product that provides value to your customers can be a daunting task, especially if you are using outdated, manual methods for quality management. Increasing efficiency and reducing instances of...

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Tags: document control, Compliance, document workflow automation, automation, regulatory

The Best 21 CFR Part 11 Compliant Software Has These Features

If your company is required to adhere to FDA 21 CFR Part 11 compliance, a document management system can make this process simple. However, not every system is built the same, and there are certain features your company should look for in a DMS...

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Tags: 21 CFR compliance, Compliance, Document Compliance Software

How to Move Beyond Compliance in 2020

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Tags: 2020 trends, 2020, Compliance, Document Compliance Software