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How Do Medical Device Manufacturers Maintain Data Integrity?

April 2nd, 2015 by Henry Macartney

How Do Medical Device Manufacturers Maintain Data Integrity? Is cybersecurity something you consider when designing a new product? As. [...] Read More

Posted in FDA & European Regulations

What Color Pen Can I Use to Sign Documents?

August 14th, 2014 by James Francum

What Color Pen Can I Use to Sign Documents? Not sure which pen to use? Although it seems like an amusing topic, your choice. [...] Read More

Posted in Pen Colors for Signing Documents

Defining Critical Quality Attributes in the Pharmaceutical Manufacturing Process

July 15th, 2014 by Zuhdi Hussein

Defining Critical Quality Attributes in the Pharmaceutical Manufacturing Process Pharmaceutical firms that wish to create product lines and cater to consumers. [...] Read More

Posted in Risk Management

Instituting Effective FDA Gap Analysis Policies

April 25th, 2014 by Zuhdi Hussein

Instituting Effective FDA Gap Analysis Policies When GxP firms take actions to maintain compliance with recommendations from. [...] Read More

Posted in Quality Systems Regulation

IT Infrastructure Qualification: Keeping GxP Firms Tech-Compliant

March 26th, 2014 by Zuhdi Hussein

IT Infrastructure Qualification: Keeping GxP Firms Tech-Compliant Medical device manufacturers and pharmaceutical companies use advanced IT tools. [...] Read More

Posted in Quality Systems

The European Medical Device Directive As It Compares To 21 CFR 820

March 10th, 2014 by James Francum

The European Medical Device Directive As It Compares To 21 CFR 820 The European Medical Device Directive or 93/42/EEC regulates which medical. [...] Read More

Posted in QSR