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...
Guide to Deviation Management Process
When you are a pharmaceutical or medical devices manufacturer, you will be conscious of the...
Engineering Change Order (ECO): Definition, Process, and More
Medical device manufacturers tend to constantly improve their processes and systems for various...
The Simple Guide to Supplier Qualification in Life Sciences
If you work in a Life Science company, be it medical device, pharmaceutical, biotechnology,...
Laboratory Audits: Overview, Guide, and Tips
Regulatory bodies such as the ISO and the FDA frequently evaluate laboratory operations to check...
Medical Device Audits: Overview, and Tips
Being a medical devices company, you are well aware of the fact that your products must be made to...
Corrective and Preventive Action (CAPA) Report
CAPA reports are critical in every regulatory inspection for medical devices, pharmaceuticals, and...