Is your organization a part of the food chain?

The exploding and irreversible pace of globalization has brought in its wake changes in almost all areas of human activity. Goods and commodities that were once confined to one’s local area have now started reaching out to the unlikeliest corners of the world. One of the most active and important of such items to undergo […]

ISO 9001’s Process Approach to Quality Management

ISO 9001 came into being exclusively as a means of incorporating a process approach to quality management systems. Both ISO 9000 and ISO 9004 underwent an amendment in 2000 to put this approach into place. It is all about process Where this approach differs from the previous standard is that it improves upon it by […]

GxP in Computer System Validation

GxP in Computer System Validation. GxP (Good X Practice, where according to FDA compliance; X can mean Clinical, Laboratory, Manufacturing, Pharmaceutical, etc., and used according to the situation in which they occur) in Computer System Validation occupies a position of primacy in the field of technology because of various reasons. The important ones among these […]

Six Systems Approach to Pharmaceutical cGMP Regulations

Six Systems Approach to Pharmaceutical cGMP Regulations. The FDA has enacted several pharmaceutical cGMP regulations. These are key concepts that are critical to quality systems. Some of the concepts by which the FDA and other regulatory bodies ensure cGMP regulations are Quality, Quality by Design (QbD) and product development, Quality Risk Management, Corrective and Preventive […]

SOX compliance training

SOX compliance training is a new requirement that publicly held companies and other CPA’s have to comply with. The SOX Act (Sarbanes Oxley Act) was a landmark legislation passed by the Congress in 2002. The primary purpose of this Act was to bring about greater accountability among businesses, especially publicly held companies and their auditors. […]