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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.

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.

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…

The Next Pharmaceutical Market Capital?
Despite political hurdles and an economic recession, Brazil is forecasted to move up in the pharmaceutical world.

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…

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…

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…

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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