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

Disruptive Pharma: 4 Innovation Trends to Watch

[fa icon="calendar'] Mon, Sep 18, 2017 / by Rachel Beavins Tracy

Wikipedia. Smartphones. LED light bulbs. Ride-share services like Uber and Lyft. All of these innovations have turned traditional industries on their head in recent years, a pointed reminder that exponential change is possible even in the most well-established sectors of the economy

The pharmaceutical industry is ripe for this kind of disruptive innovation, facing challenges that include rising costs, aging patient populations and negative public image.

What form will the next major disruptive innovation take?

This post looks at 4 innovation trends to watch.

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Life Sciences

Should Life Science Companies Comply with ISO 9001 or ISO 13485…or Both?

[fa icon="calendar'] Tue, Sep 05, 2017 / by Alexa Sussman

Many Life Science organizations are asking that question as new ISO deadlines approach.

Medical device manufacturing companies need to comply with a regulatory standard to maintain compliance and be sure that products are safe and effective. But there are multiple options that complicate the process of deciding which standard to comply with. Some make the decision to comply with more than one for the sake of covering all bases.

Here’s a breakdown of what Life Science organizations should consider about the two most common standards for medical device companies: ISO 9001:2015 and ISO 13485: 2016.

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ISO 9000 Life Sciences iso 13485

Are You Ready for Serialization?

[fa icon="calendar'] Wed, Jul 26, 2017 / by Rachel Beavins Tracy

The 2013 Drug Supply Chain Security Act (DSCSA) is aimed at improving end-to-end traceability of pharmaceuticals throughout the supply chain. Implementation of the law started with lot-level management in 2015, with item serialization requirements kicking in as early as November.

Despite the fast-approaching compliance deadline, a recent survey showed that more than 1 in 3 pharmaceutical companies and contract packagers aren’t ready. If your company is one of them, it’s time to familiarize yourself with requirements and compliance strategies to avoid unplanned downtime or regulatory issues.

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Life Sciences

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