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21 CFR Part 11,
Compliance Consulting,
Cybersecurity,
Data Integrity,
QMS,
Quality Management Systems

What Data Integrity Means to Device Manufacturers

By Zuhdi Hussein on June 12, 2020

Data integrity is an ever-increasing concern in life sciences, with medical device manufacturers feeling much of the conformity backlash. There continues to be heightened regulatory focus on diverse cybersecurity topics, including data integrity.

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CAPA Systems,
Compliance Consulting,
compliance consulting,
Deviation Management,
FDA Compliance,
GxP CC,
Quality Management Systems

Meeting Compliance Goals With Deviation Management And CAPA Systems

By Henry Macartney
on June 02, 2014

Your firm will experience compliance failures from time to time. In the realm of complex GxP-regulated processes, like automated pharmaceutical manufacturing and medical device quality assurance, things can go wrong with little advance warning.

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