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IT Infrastructure Qualification: Keeping GxP Firms Tech-Compliant

March 26th, 2014 by Zuhdi Hussein

Medical device manufacturers and pharmaceutical companies use advanced IT tools. [...] Read More

Posted in Quality Systems

Quantifying The Value Of An FDA Mock Audit For Medical Device Manufacturers

March 21st, 2014 by James Francum

FDA and ISO inspections are extremely stressful, but they play vital roles in. [...] Read More

Posted in Quality System/GMP Regulation

Using Audits To Improve Your Supplier Quality And Performance

March 19th, 2014 by James Francum

Supplier oversight and quality is imperative in maintaining the integrity of. [...] Read More

Posted in Medical Device Supplier Audits

FDA Demands Full Compliance With GMP Requirements in the Pharmaceutical Industry – To What Extent Is Compliance Required?

March 12th, 2014 by James Francum

The most succinct answer to the question of what determines FDA compliance with. [...] Read More

Posted in Medical Device and Pharmaceutical Production Facil

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

March 10th, 2014 by James Francum

The European Medical Device Directive or 93/42/EEC regulates which medical. [...] Read More

Posted in QSR

Risk and Supply Chain Security – Meeting the Demand for Compliance

March 6th, 2014 by James Francum

Companies which manufacture and distribute pharmaceuticals in domestic or. [...] Read More

Posted in Supply Chain Management

Cybersecurity Regulations in a GxP Environment

March 4th, 2014 by James Francum

Modern medical devices bear an increased capacity for advanced data processing.. [...] Read More

Posted in Securing Mobile Medical Devices

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