In any industry, and particularly so in the life sciences industry, the basis of an organization’s efficient Quality Management System (QMS) is proper documentation. As a life science organization, you will understand the importance of quality at all levels. Quality,...
If you are a medical device company, you will understand the need to comply with both international and regional regulatory rules and regulations. A very important regulatory quality standard that is enforced by the US FDA (21 CFR Part 820.198) in the North American...
The ICH Q10 pharmaceutical quality system document is an all-inclusive manuscript that serves as a model for an efficient quality management system (QMS) in the pharmaceutical industry. By implementing the ICH Q10 pharmaceutical quality system you will demonstrate to...
Standard Operating Procedures (SOPs) are an integral part of the day-to-day operations in the pharmaceutical industry, and every department must have its own SOPs. It is against regulatory requirements to execute operations without a properly developed, approved, and...
As a medical device manufacturer planning to sell your devices in the European Union (EU) market, you will first need to demonstrate compliance with EU regulatory requirements. You will ascertain this conformity by preparing meticulous information about the design,...
