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Can Your Choice of Software Affect Your FDA Part 11 Compliance Efforts?

July 29th, 2014 by Zuhdi Hussein

FDA 21 CFR Part 11 isn't as broad as some regulations. Nonetheless, it's. [...] Read More

Posted in GxP CC

How Can Your Firm Use Quality Risk Management?

July 25th, 2014 by Henry Macartney

Regulatory compliance can be tricky, especially when it comes to your. [...] Read More

Posted in Quality Risk Management

Principles of Quality Risk Management: Implementing ICH Q9

July 17th, 2014 by James Francum

As you make efforts to adhere to guidelines and regulations created by diverse. [...] Read More

Posted in Quality Risk Management

Defining Critical Quality Attributes in the Pharmaceutical Manufacturing Process

July 15th, 2014 by Zuhdi Hussein

Pharmaceutical firms that wish to create product lines and cater to consumers. [...] Read More

Posted in Risk Management

What Makes a Quality Management System Effective?

July 11th, 2014 by Henry Macartney

Modern quality management systems are often called upon to help their users. [...] Read More

Posted in Quality Management Systems

Getting Compliant With FDA 21 CFR Part 11

July 7th, 2014 by James Francum

The FDA requires medical device manufacturers, pharmaceuticals manufacturers,. [...] Read More

Posted in Software and IT Systems Validation

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