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...
ISO 13485:2016 Audit: Overview, Audit Types and Execution
ISO 13485 audit provides an objective measure of the organizations’ processes and regulatory...
Corrective and Preventive Action (CAPA) Procedure
Corrective and preventive action (CAPA) procedures are critical to the success of the quality...
What Is CAPA in the Medical Device Industry?
CAPA consists of a specific set of actions that an organization must complete to resolve and...
What is CAPA in the Pharmaceutical Industry?
Product quality is a key factor for any pharmaceutical organization and the CAPA process helps...
Corrective Action and Preventive Action (CAPA) Form
A CAPA form is a tool used to initiate the CAPA process from different non-conformance events....
What Is Device Master Record (DMR) and Why Is It Important?
A Device Master Record (DMR) is a collection of all the records that must be used to produce a...
Design Controls for Medical Devices
Design Controls indicate that the medical devices your company makes are both safe and efficacious...