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Key Characteristics of FDA Part 11 Compliance

February 4th, 2016 by

Ultrasound Properly managing sensitive information to maintain privacy and security has become paramount in recent years. Today, [...] Read More

The Applicable Scope of FDA 21 CFR Compliance

September 9th, 2014 by

Electronic SignaturesRegulatory [...] Read More

What Goes into CSV Compliance?  

September 5th, 2014 by

Computer System ValidationMost of the more [...] Read More

How Can Your Firm Implement QSIT Principles?

August 25th, 2014 by
QSIT Principles

Are You Using QSIT Principles?

Today’s medical device manufacturers must be [...] Read More

Can Your Choice of Software Affect Your FDA Part 11 Compliance Efforts?

July 29th, 2014 by

Electronic Records[...] Read More

What Makes a Quality Management System Effective?

July 11th, 2014 by

Quality Management SystemModern quality management systems are often called upon to help their users meet varied regulatory standards and guidelines. For instance, your company may employ a single [...] Read More

Medical Device Risk Management and ISO 14971

June 26th, 2014 by

ISO 14971[...] Read More

Meeting Compliance Goals With Deviation Management And CAPA Systems

June 2nd, 2014 by

Deviation ManagementYour firm will experience compliance failures from time to time. In the realm of complex GxP-regulated [...] Read More

Implementing Comprehensive Quality Systems For FDA Medical Device QSR And Other Regulations

May 12th, 2014 by

FDA QSR ComplianceThe FDA’s Quality System Regulation shouldn’t [...] Read More

Using Software Validation Of IT Systems For FDA Compliance

April 16th, 2014 by

IT Software ValidationCompanies which must work in a GxP environment rely on a range of different technologies to maintain consistent quality and levels of output. In addition to the control software these organizations employ to manage their manufacturing and marketing operations, modern companies also [...] Read More