The FDA 21 CFR Part 11 Compliance and Data Integrity

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:

  • Unique user logins and authentication tools
  • Detailed audit trails including file creation/modification/deletion/metadata
  • Electronic Signatures

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.

Companies who rely on PAX-it!:

Merck, PAX-it - Trusted by Companies Around the World
ExonMobil, PAX-it - Trusted by Companies Around the World
Pfizer, PAX-it - Trusted by Companies Around the World
Medtronic, PAX-it - Trusted by Companies Around the World
Abbott, PAX-it - Trusted by Companies Around the World
NASA, PAX-it - Trusted by Companies Around the World
Firestone, PAX-it - Trusted by Companies Around the World
Bristol-Myers Squibb, PAX-it - Trusted by Companies Around the World
Centers for Disease Control and Prevention
Lucent Technologies, PAX-it - Trusted by Companies Around the World
GE Imagination at Work
Texaco, PAX-it - Trusted by Companies Around the World
Hewlett Packard, PAX-it - Trusted by Companies Around the World
Procter and Gamble, PAX-it - Trusted by Companies Around the World
Dupont, PAX-it - Trusted by Companies Around the World

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.


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