To be compliant, an image database must feature secure, time-stamped audit trails which document any processes applied to an image. To help its user-base meet these stringent requirements, PAX-it! has rolled out a number of additional security features to their existing image management software.
Extended security features include:
This extract from the FDA outlines the primary Part 11 requirements referring to Electronic records.
The screenshots shown from PAX-it! software shows that multiple signatures can be applied to a single record however no more than one user can sign an image. Each signed image is date/time stamped with the users unique identification code followed with a reason/meaning as per 21 CFR 11.50 above.
The screenshots shown from PAX-it! software shows that multiple signatures can be applied to a single record however no more than one user can sign an image. Each signed image is date/time stamped with the users unique identification code followed with a reason/meaning as per 21CFR11.50 above
The 21 CFR Part 11 guidelines for electronic signatures are referenced below with an extract from PAX-it! software showing how this is addressed in the software.
To digitally sign an image in PAX-it the user must enter a unique username and password as per 21CFR11.200 above.
Once the image is digitally signed this is logged and cannot be modified in any way from the original image. Annotations such as measurement can still be performed but the original image is not modified in any way, a copy of the image is made.
As the principal distributor for PAX-it! in the UK and Irish market, Mason Technology can advise and install the compliant software in your business. Get in touch with one of our team for further information on how PAX-it! can benefit your organisation.
