Laboratory Compliance Risk Assessment Guide
The FDA and other regulatory bodies continue to focus on Data Integrity, which has globally elevated the profile of laboratory compliance. Laboratories in many regulated industries must find a way of balancing continued operation of the lab with performing essential gap analysis and lab improvement projects to satisfy compliance and data integrity requirements.
This risk evaluation guide can be used to help identify potential compliance risk exposure for analytical instruments, laboratory software or aspects of laboratory audit preparation for regulated labs.
Please select one or more of the three risk areas to evaluate your risk profile. For each risk area of interest, read and answer ALL the questions in that section. Then click “Submit”.
This risk evaluation guide has been developed to support laboratories gaining a deeper understanding of their potential compliance risk exposure. The information provided should be used as an indicative guide only, as it is calculated from the responses to the questions and not on audit of the facilities.
Laboratories are responsible for the integrity and compliance of the analytical data they generate, which must satisfy the applicable laws and regulations for the countries where they provide their products and services.
Agilent CrossLab Group has developed a number of products and services to help laboratories satisfy their regulatory requirements, including an automated compliance solution designed to support the end-to-end Analytical Instrument Qualification (AIQ) process, Computer System Validation (CSV) starter kits and compliance consulting. Contact Agilent to find out more about these services.