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

July 29th, 2014 by

Electronic Records[...] Read More

How Can Your Firm Use Quality Risk Management?

July 25th, 2014 by

Quality Risk Management[...] Read More

Principles of Quality Risk Management: Implementing ICH Q9

July 17th, 2014 by

ICH Q9 Risk ManagementAs you make efforts to adhere to guidelines and regulations [...] Read More

Defining Critical Quality Attributes in the Pharmaceutical Manufacturing Process

July 15th, 2014 by

Quality By DesignPharmaceutical firms that wish to create product lines and cater to consumers as [...] 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

Getting Compliant With FDA 21 CFR Part 11

July 7th, 2014 by

FDA 21 CFR Part 11The FDA requires medical device manufacturers, pharmaceuticals manufacturers, biotech [...] Read More