FDA Title 21 CFR Part 11 and Data Integrity relates to image storage and manipulation.

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:

  • Unique user logins and authentication tools
  • Detailed audit trails including file creation/modification/deletion/metadata
  • Electronic Signatures
Mason Technology
Electronic records and signatures to keep your assets secure, complete with authentication tools and alertsDetailed audit trails that track all digital manipulations, and provide a searchable report of all changesAll image files are retained by the system. If the user saves a newer version of an image, it is assigned as a copy of this image and does not overwrite the original data.Administrative tools including unique logins and user permissions

Examples of how PAX-it! complies with 21 CFR Part 11 are below:

This extract from the FDA outlines the primary Part 11 requirements referring to Electronic records.

Mason Pax-It FDA

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 

Mason Pax-It Reason

Mason Pax-It Fail Pass

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.

Mason Pax-It 21CFR11 Guidelines

To digitally sign an image in PAX-it the user must enter a unique username and password as per 21CFR11.200 above.

Mason Pax-It 21CFR11 Digitally Assign

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.

Mason Pax-It Completion

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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