Change Control Process
An efficient change control process is nowadays essential for any Quality Management System within a regulated environment and both FDA and EU MDR 2017/745 requests particular attention to the management
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 to obtain a certification that takes in consideration the applicable
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 of data, from the process design stage throughout production, which establishes
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 the internationally recognised best approach for computer system validation. GAMP
Device Master Record
The device master record is a design document specifically requested by the FDA Quality System Regulation, as per 21 CFR 820.181. If we follow the definition reported in the regulation:
