How Can Your Firm Use Quality Risk Management?

July 25th, 2014 by

Quality Risk ManagementRegulatory compliance can be tricky, especially when it comes to your overarching quality management services. There are many guidelines, regulations and laws to understand in order to be compliant in [...] 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 gap-analysis scheme to prepare your production lines for FDA and ISO audits and alike and simply plug in [...] Read More

The Dangers of Relying Solely on General Guidelines to Perform Software Validation for FDA Compliance

February 18th, 2014 by

Software Validation ComplianceThe FDA has established, via the issuance of General Principles of Software Validation, far reaching and comprehensive validation requirements relating to all software utilized for “…design, [...] Read More