Operating SEM-EDS in a regulated environment
The pharmaceutical industry is one of the most regulated industries in the world. But, until very recently, analytical techniques such as SEM-EDS were exempt from these regulations due to the non-routine nature of SEM analysis. This has now changed with the introduction of good practice quality guidelines such as ‘GxP’, and regulations such as 21 CFR part 11 and Annex 11. These guidelines and regulations are designed to ensure that electronic records are secure, trustworthy and reliable.
In this webinar, Anthony Hyde, from Oxford instruments, and Jill Webb, Associate Principal Scientist at RSSL, will highlight some of the common applications carried out by SEM-EDS users in pharmaceutical facilities.
Learn how SEM-EDS users must work closely with IT and quality managers to generate and implement standard operating procedures (SOP) to ensure that any analysis carried out in their laboratories conforms with regulations such as 21 CFR part 11 and Annex 11.
They will also demonstrate how the AZtecPharma SEM-EDS system not only allows EDS analysis to easily be incorporated into SOPs, but also enables users to improve their productivity and the quality of their results with:
- Individual user logins
- Digital signatures
- Data audit trails
- Tru-Q
- Live chemical imaging