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…
FDA Labelling Requirements: An Overview
FDA labelling Requirements
What are the best Methods for Root-Cause Analysis ?
Performing an investigation in case any type of deviation occurs is of fundamental importance nowadays and root-cause analysis methodologies play…
How to be compliant with ISO 27001?
Tips for implementation of the ISMS ISO 27001 is an international standard providing requirement for the implementation of the information…
ISO 62366 and Usability Requirements for Medical Device
ISO 62366 plays a fundamental role in the design process for medical device as it explains the requirements related to…
Management Review
General Requirements It is important to demonstrate that top management reviews the suitability, adequacy and effectiveness of the organization’s quality…
Easy Guideline to GXP Compliance
GXP requirements became more and more important in the last years. In this post, we provide an easy guideline to…
IEC 62304:2006 – Medical Device Software
IEC 62304:2006 is an internationally recognised medical device standard which provides a framework for the development, testing and maintenance of…
Corrective and Preventive Actions (CAPA)
There is no doubt that CAPA (Corrective and Preventive Actions) is one of the most important process of any Quality…