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Blog » Archive by category "compliance consulting"

What Data Integrity Means to Device Manufacturers

August 28th, 2015 by Zuhdi Hussein

Data integrity is an ever-increasing concern in life sciences, with medical. [...] Read More

Posted in Quality Management Systems

Outsourcing and the Device Manufacturer’s QMS Accountability

August 6th, 2015 by Henry Macartney

In 2003, the International Organization for Standardization (ISO) issued ISO. [...] Read More

Posted in Medical Device Quality Management Systems

A Flexible Approach to 21 CFR 820 Compliance

June 11th, 2015 by Henry Macartney

The Quality Systems (QS) Regulations of FDA 21 CFR 820 are general standards. [...] Read More

Posted in Quality Systems Regulations

Will 21 CFR 11 Hinder My Compliance Efforts?

March 31st, 2015 by James Francum

Electronic records are complex by nature. While they ostensibly serve as. [...] Read More

Posted in FDA regulations

Choosing the Most Effective IT Infrastructure Qualification Strategies

January 27th, 2015 by Henry Macartney

Are you sure your IT infrastructures are fully qualified, or is it possible. [...] Read More

Posted in Software Validation

Meeting Compliance Goals With Deviation Management And CAPA Systems

June 2nd, 2014 by Henry Macartney

Your firm will experience compliance failures from time to time. In the realm. [...] Read More

Posted in Quality Management Systems

Can Medical Device Compliance Consulting Benefit You?

April 29th, 2014 by Henry Macartney

As all medical device manufacturers know, life sciences firms are bound by GxP. [...] Read More

Posted in Supply Chain Management

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

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