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.Read More
It’s that time of year again—time to celebrate family, friends and food. But most importantly, it’s time to reflect on what you’re thankful for. We did that here at EtQ, and thought we’d share some responses from our team.Read More
When faced with challenges you have two options: become a victim of circumstance or use the tools around you to turn them into an opportunity. With a Quality Management System (QMS), you can easily turn many operational challenges into opportunities for success.Read More
Two main ideas that Samurais reflect are training hard and preparing for the worst. That way, they are calm, cool and collected when attacked and can rely on their strong skillset to help them succeed.
Your quality management approach shouldn’t be all that different. Preparing like a Samurai could help your organization better handle the battle of adverse quality events.Read More
Scrambling to find a last-minute costume for your quality themed Halloween party? Don’t worry, we’ve got a few ideas for you.Read More
Almost 30 accidents occurred this year at BP’s operations site in Alaska. Of those incidents, five were considered “Tier 1 events,” which put the lives of employees at risk.
“We must change now,” said BP Alaska President Janet Weiss. “We must have a reset.”
The change she’s referring to is a change in safety culture. Out of date safety processes and a disengaged safety culture are causing these incidents that, if continue, will result in death or irreparable damage.
So what can BP—and companies in similar positions—do to overhaul their safety culture and make permanent changes?
Here are three aspects of EHS management to utilize to promote an improved safety culture.Read More
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.Read More
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.Read More
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.Read More
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.Read More