Compliance

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Using Automation Technology to Manage Regulatory Compliance

Now more than ever, the demand for safe and effective medical drugs is increasing on a global scale. This means that regulatory affairs teams are working overtime to interpret, apply, and communicate the guidelines received from governing bodies like the FDA and EMA when it comes to developing new drugs.

Featured Posts

July 27, 2020

Using Automation Technology to Manage Regulatory Compliance

August 28, 2019

What to Expect as GDPR Makes Its Way to the United States

May 27, 2019

UK Manufacturers Ponder Post-Brexit Proofreading Impact on Packaging

April 15, 2019

FDA Regulatory Compliance Affects All Aspects of Manufacturing… for the Better

March 27, 2019

Following FDA Data Integrity Guidelines Is Easier than You Think

January 18, 2019

The Undeniable Need for Digital Proofing in Regulatory Affairs

December 18, 2018

The Era of Electronic Signatures Has Arrived

December 11, 2018

The Next Pharmaceutical Market Capital?

by Kayla Caticchio | July 28, 2020

Compliance

What to Expect as GDPR Makes Its Way to the United States

It’s a year into life post-GDRP. Amazingly, the world goes on. In fact, the General Data Protection Regulation in the European Union has gone according to plan, to the point that similar legislation is being considered in other parts of the world, including the United States.

Background image of London with BREXIT text

Compliance

UK Manufacturers Ponder Post-Brexit Proofreading Impact on Packaging

With United Kingdom Prime Minister Theresa May announcing her resignation, the country’s economic future with Brexit looming over its head is as uncertain as ever. Imagine how individual companies are feeling in the aftermath of her decision and ultimate inability to negotiate a deal for Britain’s exit from the European Union.

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Compliance

FDA Regulatory Compliance Affects All Aspects of Manufacturing… for the Better

There’s a saying: “Winning isn’t everything; It’s the only thing.” In business however, before you can win, you have to first comply with regulations.

Cartoon women standing with FDA icon and check mark

Compliance

Following FDA Data Integrity Guidelines Is Easier than You Think

Of note, the Food and Drug Administration (FDA) has official data integrity guidelines, out in full force as we speak. However, firms who are already following current Good Manufacturing Practices (cGMP) have nothing to worry about.

Compliance

The Undeniable Need for Digital Proofing in Regulatory Affairs

Still in its relative infancy as a discipline, regulatory affairs was created to meet a pressing need, regardless of the industry in question.

GlobalVision software on Phone, Tablet and laptop

Compliance

The Era of Electronic Signatures Has Arrived

A name on a dotted line may technically hold just as much legal weight as ever, but in the era of electronic signatures a contract can be enforced without a pen ever touching paper. What Are Electronic Signatures? Indeed, electronic…

Cartoon characters working with pills bottles packages

Compliance

The Next Pharmaceutical Market Capital?

Despite political hurdles and an economic recession, Brazil is forecasted to move up in the pharmaceutical world.

Compliance, Proofreading

FDA Break-Down: What is the FDA, FDA 21 CFR and How Do You Stay Compliant?

What is the FDA? The Food and Drug Administration is a government agency that operates under the United States Department of Health and Human Services. The FDA is responsible for protecting and ensuring public health in…

Compliance

Why ISO 9001:2008 Certification is Vital for Companies

How can you define product quality? This term can be interpreted in different ways depending on the country or region you live in, but perhaps the most crucial variable that determines what quality represents is the unique set of quality objectives…

Every company needs change, but in the midst of implementing it, only a few of them think about ISO 9000.

Compliance

Looking for Process Change? Think ISO 9000

Every company needs change, but in the midst of implementing it, only a few of them think about ISO 9000. It is mostly perceived as a purely technical standard that only specific industries have to deal with. But for the experienced business…

Compliance, Proofreading

Having to Rework Label Artwork Again and Again to Stay in Compliance?

No matter what industry you are in there are always new regulations which impact the way you create labelling artwork. Staying in compliance with regulatory labeling obligations is a complex undertaking that if done wrong may result in undesired…

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Compliance

Using Automation Technology to Manage Regulatory Compliance

Featured Posts

Using Automation Technology to Manage Regulatory Compliance

What to Expect as GDPR Makes Its Way to the United States

UK Manufacturers Ponder Post-Brexit Proofreading Impact on Packaging

FDA Regulatory Compliance Affects All Aspects of Manufacturing… for the Better

Following FDA Data Integrity Guidelines Is Easier than You Think

The Undeniable Need for Digital Proofing in Regulatory Affairs

The Era of Electronic Signatures Has Arrived

The Next Pharmaceutical Market Capital?

What to Expect as GDPR Makes Its Way to the United States

UK Manufacturers Ponder Post-Brexit Proofreading Impact on Packaging

Keep Reading

FDA Regulatory Compliance Affects All Aspects of Manufacturing… for the Better

Following FDA Data Integrity Guidelines Is Easier than You Think

The Undeniable Need for Digital Proofing in Regulatory Affairs

The Era of Electronic Signatures Has Arrived

The Next Pharmaceutical Market Capital?

FDA Break-Down: What is the FDA, FDA 21 CFR and How Do You Stay Compliant?

Why ISO 9001:2008 Certification is Vital for Companies

Looking for Process Change? Think ISO 9000

Having to Rework Label Artwork Again and Again to Stay in Compliance?

Stay updated with GlobalVision by signing up for our newsletter.

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