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Timothy Reinhardt
By Timothy Reinhardt on November 17, 2020

Shifts in the landscape of quality management training

When I started in the pharmaceutical industry nearly thirty years ago, training meant collecting large numbers of various staff members into a conference room on a slow day and methodically walking through a high-level general presentation packed with incidental information. This exercise was repeated annually for my first three years, with what seemed to me to only contain tiny alterations to the training material. Proficiency, engagement, and creativity were not a driving factor in the sessions. It seemed more about filling an afternoon and checking a box.
Mike Kent
By Mike Kent
on November 12, 2020

Tenth grade. High school. Speech class. Six words that, to most of us, including me, bring back various thoughts and emotions. Maybe one of those emotions is “fear”? But what if I told you that back then, and still today, you and I both have everything we need to be able to speak in front of a group of a thousand strangers? We are able to manipulate our mouth and breath in such a way as to generate words in a certain language.

But is “ability” or “competency” the desired outcome? 

Sam Heck
By Sam Heck
on October 09, 2020

Access to the same validated, powerful tool we use

We believe that we’re all better when we control quality together. That’s why we’re excited to announce the launch of our  new import/export tool for our broader ZenQMS community. It’s the same powerful, validated tool that our Customer Success and Development teams use for importing/exporting data around change control and issues. We’ve designed a user-friendly front end so that you can set your own pace and accelerate your process.

Steve Diedrich
By Steve Diedrich
on September 15, 2020

As part of the Quality Leaders Forum, we sat down (virtually) with Steve Diedrich for a primer on compliance vs. quality and how we might use Simon Sinek's framework of "finite and infinite games" to think about quality management. Register now for "Playing the Infinite Game in Quality," an interactive forum with Steve Diedrich. 

Jen Rajchel
By Jen Rajchel
on August 10, 2020

Actionable insights, confidence in completed tasks, and clear context are key to managing quality, so we're excited to share with you how our 2020.2 release can help. 

Celia Brown
By Celia Brown
on April 20, 2020

With travel bans and stay-at-home orders in place throughout the US and many other countries, life sciences companies are struggling to maintain GxP compliance under increasingly challenging circumstances. Employees are working remotely- and so are FDA inspectors and auditors. And new regulations are being rolled out frequently in hopes of expediting the drugs, devices, and vaccines supporting the treatment and prevention of COVID-19.  

Panos Boudouvas
By Panos Boudouvas
on April 07, 2020

Amidst this turbulent moment in our lives, with a global pandemic threatening us and our loved ones directly, and the specter of the coming economic recession already making waves, it is important to acknowledge that the hard work of life sciences development and manufacturing continues.  And while global regulatory requirements remain in place, many companies will be forced to stretch budgets further and possibly with fewer FTEs (due to cuts). And in a new complication-- teams will have to truly do more (or everything!) remotely-- manage policies and related training compliance, investigate deviations, manage change controls, host/conduct audits, sign/review documents, etc. 

Celia Brown
By Celia Brown
on March 31, 2020

As COVID-19 continues to spread across the globe, governments urge citizens to self-quarantine, and the U.S. economy faces an uncertain future, the life sciences industry is under more pressure than ever. Pharmaceutical and healthcare companies continue to work toward the development of a vaccine and therapies for the respiratory infection that was declared a pandemic by the World Health Organization last week. And the FDA is rolling out updated policies to streamline the path to an effective vaccine and protecting the public from fraudulent products. 

Panos Boudouvas
By Panos Boudouvas
on March 17, 2020

A message to our community of customers and partners:

By Judy Carmody
on March 16, 2020

What are the two inspectional focus areas of regulatory agencies? Vendor oversight and data integrity. And agencies expect companies to take a risk-based approach, making them both quite daunting tasks.