Change Control Process
An efficient change control process is nowadays essential for any Quality Management System within a regulated environment and both FDA…
MDSAP : Medical Device Single Audit Program
The MDSAP is an audit program that allows auditing organization to perform a single audit of a medical device manufacturer…
Process Validation for Medical Devices: Overview of FDA Requirements
What is Process Validation? Medical device process validation and the related IQ/OQ/PQ technique, is defined as the collection and evaluation…
GAMP-5 Guidance for Computer System Validation
GAMP-5 guidance, the related “V model” and the different software categories used to simplify the validation activities are nowadays considered…
Device Master Record
The device master record is a design document specifically requested by the FDA Quality System Regulation, as per 21 CFR…
Design Verification vs Design Validation: What are The Differences?
Introduction to Verification vs Validation Design verification and validation are critical components of the design process when developing a medical…
FDA Requirements for UDI on Medical Devices
The UDI (Unique Device Identification) is a system used to uniquely identify medical device sold in a specific country, for…
How to write a Quality Manual fully compliant with ISO standards?
The quality manual is one of the most important documents for a company with a quality system in place, and…
21 CFR Part 11: Requirements for Electronic Records and Signatures.
Introduction of 21 CFR Part 11 Requirements FDA 21 CFR Part 11 defines the requirements for the management of electronic…
