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,...
Guide to Quality Audits in the Pharmaceutical Industry
Quality audits are crucial to ensure compliance with regulatory requirements in any industry....
Change Control in Pharma: Best Practices & Examples
The change control process is a set of coordinated activities through which the desired change is...