To be compliant, an image database must feature secure timestamped 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.
The FDA guidelines for Data Integrity include the requirement for compliance for the storage of electronic records. The current trend is to move all manual and hybrid systems to electronically stored records where 21CFR Part 11 and GMP regulations apply.
PAX-it! software facilitates the move from manual microscopes to a compliant system which uses a SQL database which is located on the client server and managed by the internal IT department.
PAX-it! software was originally designed for the US market but following consultation in the Irish and UK markets it was clear that some European requirements needed to be included in the software. Therefore we added some additional security features as detailed below.
To be compliant, an image database must feature secure timestamped audit trails which document any processes applied to an image. To help its user-base meet these stringent requirements, PAX-it! rolled out a number of additional security features to their existing image management software.
Some extended security features include:
With these tools, compliance is not an issue. Click here for the FDA website outlines the primary Part 11 requirements referring to Electronic Records.
A distinctive feature of the PAX-it! software is that it allows multiple signatures to 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 regulation 21 CFR Part 11.
To digitally sign an image in PAX-it! the user must enter a unique user name and password. 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 anyway, a copy of the image is made.
We will advise our clients to consider improving their process when making their system compliant. Moving from a manual or Hybrid system would require a change in SOP so we would advise the quality manager to improve the process in line with future trends while also improving productivity.
PAX-it! will improve efficiencies, ensure compliance for Data Integrity audits while still working to USP directives.
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