What is a Device History Record (DHR) and Why is it Important?
The complete documentation about the manufacturing and tracking of every medical device that your...
What is an eQMS (Electronic Quality Management System)?
Electronic Quality Management System (eQMS) Definition An Electronic Quality Management System, or...
Medical Device Document Control
Medical device document management and control is the underpinning of your company’s Quality...
Effective Pharmaceutical Document Management
Considering the amount of documentation that is required for pharmaceutical companies, efficient...
Clinical Quality Management System
When a life-sciences organization has an effective quality management system (QMS) in place, it is...
Quality Management System Documentation
In any industry, and particularly so in the life sciences industry, the basis of an organization’s...
Medical Device Complaint Handling Processes
If you are a medical device company, you will understand the need to comply with both...
ICH Q10 Pharmaceutical Quality System
The ICH Q10 pharmaceutical quality system document is an all-inclusive manuscript that serves as a...
SOP Management in Pharmaceutical Industry
Standard Operating Procedures (SOPs) are an integral part of the day-to-day operations in the...
Medical Device Technical File and Its Structure
As a medical device manufacturer planning to sell your devices in the European Union (EU) market,...