GxP Lifeline Newsletter
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January | 2018
MasterControl GxP Lifeline
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FDA Guidance Answers Questions Regarding Data Integrity
by David Jensen, MasterControl Staff Writer

 

An alarming increase in CGMP violations involving data integrity has come to the attention of FDA. To spotlight this issue, the regulatory watchdog has drafted a question-and-answer-based guidance, “Data Integrity and Compliance with cGMP.”

 

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QA vs. QC, Quality Control vs. Quality Management: What’s the Difference?
by Cindy Fazzi

 

In a company organized properly, quality assurance resides independent of manufacturing and operations, and quality control resides within manufacturing and operations. But what is the difference?

 

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5 Ways MasterControl Ensures System Compliance with 21 CFR Part 11
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How a Pharma Company Automates CMO Audits
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Biopharma Trends to Watch in 2018
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Industry Gears Up for Track and Trace
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Future Trends and Opportunities in Quality Assurance
by David Jensen, Staff Writer, MasterControl

 

It’s impossible to know exactly what future trends will influence the direction and methodologies of quality assurance (QA). However, according to Bristol Myers Squibb executive Donna Gulbrinski, looking at how quality professionals overcome current challenges can lend some insight on future QA strategies and processes.

 

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20 Years Later, 21 CFR Part 11 is More Relevant than Ever
by Cindy Fazzi, MasterControl Staff Writer

 

If 21 CFR Part 11 and the life science industry were a married couple, they would be celebrating their platinum wedding anniversary this year. For better or for worse, in sickness and in health, it has been 20 years of compliance. It’s an important milestone to celebrate and think about.

 

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How to Minimize Protocol Deviations
by Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

 

If you’ve seen FDA’s Inspectional Observation Summaries, you know that in 2015 the most frequently cited violation in clinical research by far was “failure to conduct research in accordance with the investigational plan.” Do you know this also topped the list the year before that?

 

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Wondering what the next five articles offer? Leadership tips, questions about ISO 13485 and 9001, and CAPA were also hot topics in 2017: 

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