Avoid FDA Warning Letters with These 4 Document Control Best Practices

[fa icon="calendar'] Fri, Feb 16, 2018 / by Rachel Beavins Tracy

Incomplete records stuffed in the trash, with the signatures still showing. Blank forms issued complete with signatures. Employees shredding documents without bothering to record why and what they were destroying, even as inspectors were onsite.

These practices may sound outrageous, but the document control horror stories are all right there in the U.S. Food and Drug Administration (FDA) warning letters. Even organizations that wouldn’t dream of engaging in such obvious violations could be subject to 483 notices and warning letters if they don’t get document control right.

With that in mind, let’s take a look at 4 document control best practices to help companies avoid FDA warning letters.

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Life Sciences

How a Good Corrective Action Plan Helps You Comply with ISO 13485:2016

[fa icon="calendar'] Fri, Jan 26, 2018 / by Alexa Sussman

quality_icons.jpgISO 13485:2016, A Review

ISO 13485:2016 is the latest revision of the standards for quality management systems in medical device manufacturers and their suppliers.

Since companies only have until September 2018 to comply with these standards, it’s important to understand the main takeaways of the latest revision:

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Life Sciences

Understanding the Basics of ISO 13485 for Medical Device Quality Management Systems (QMS)

[fa icon="calendar'] Mon, Jan 08, 2018 / by Rachel Beavins Tracy

ISO 13485 for Medical Device Quality Management Systems is growing in popularity, with the number of certified facilities jumping 13% from 2015 to 2016.

But how is ISO 13485 different from ISO 9001 for Quality Management, and who should certify?

In this post, we’ll take a look at the basics of ISO 13485 to help you decide whether it’s worth pursuing this certification.

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Life Sciences

4 Risk Management Gaps and Opportunities [Infographic]

[fa icon="calendar'] Thu, Dec 07, 2017 / by Rachel Beavins Tracy

To achieve operational excellence, you need a comprehensive, forward-thinking approach to managing safety and quality risks.

This infographic identifies 4 of the most common risk management gaps and shows you how solutions like quality management software can help mitigate these risks.

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Quality Management Life Sciences Food and Beverage EHS Risk Management

6 FDA-Recommended Considerations for Smart and Safe Medical Device Interactions

[fa icon="calendar'] Wed, Nov 29, 2017 / by Alexa Sussman

In September 2017, the FDA announced a guidance called “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.” This guidance will help Life Science organizations via considerations for design and development of medical devices to safely exchange information.

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Life Sciences

Tips for Managing the Top 5 Life Sciences Risks [Infographic]

[fa icon="calendar'] Tue, Nov 07, 2017 / by Rachel Beavins Tracy

Life sciences companies face risks that threaten product quality, patient safety and profitability--this infographic reviews these risks and provides tips for mitigating them. Read More

Life Sciences Risk Management

Best Practices for Prioritizing Pharmaceutical Serialization

[fa icon="calendar'] Tue, Oct 10, 2017 / by Alexa Sussman

The 2013 Drug Supply Chain Security Act (DSCSA) is full swing in its implementation phase. This act hopes to drastically reduce—or even eliminate—counterfeit, altered or incorrect drugs in the pharmaceutical market.

Some requirements under this act include providing electronically formatted transaction data to trading partners, timeframes on replying to verification requests, verifying product identifiers of suspect and returned items and quarantining suspect products and clearing or disposing of them. But the most impactful change is the requirement of product serialization.

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Life Sciences

What Life Science Companies Can Learn from Former Equifax CEO Richard Smith

[fa icon="calendar'] Wed, Oct 04, 2017 / by Alexa Sussman

On Tuesday, former Equifax CEO Richard Smith testified before the House Energy and Commerce Committee about the credit firm’s recent massive security breach.

Although Smith took full responsibility for the breach occurring under his leadership, congress was unsatisfied with his apologies and criticized his lack of actions immediately following the incident.

“It’s like the guards at Fort Knox forgot to lock the doors and failed to notice thieves emptying the vaults,” said Greg Walden, the Republican chairman of the House subcommittee.

This issue brings to light the very real threats to cybersecurity—and Life Science organizations should take heed.

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Life Sciences

A Look into Artificial Intelligence in Medical Devices

[fa icon="calendar'] Mon, Sep 25, 2017 / by Alexa Sussman

Sharing a name with one of the most popular Artificial Intelligence (AI) technologies of current times (thanks for that, Amazon), I’ve learned a thing or two about what AI is capable of. Beyond summoning your road trip playlist or helping your figure out what actor was in that movie you watched last week, AI is capable of more than you could imagine.

The medical device industry has noticed this too—and they’re using it to save lives.

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Life Sciences

New Video: A Quality Management Platform for Businesses of Every Size

[fa icon="calendar'] Wed, Sep 20, 2017 / by Alexa Sussman

Humans are a progressive species, always looking to innovate and move forward. But with progress comes change, and change brings new risks.

That’s where EtQ comes in. For over 25 years, we’ve been the constant support businesses need to move forward. We’re with you every step of the way, growing and scaling as your business adapts in a fast-paced environment.

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Quality Management Life Sciences Food and Beverage EHS

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