Zetasizer: 21CFR? Electronic Record/Electronic Signature? Test Schedule?


FDA-21-CFR-part-11-compliant 21CFR part 11 compliant software version for the Zetasizer to allow GMP operation in your pharmaceutical laboratory

What about 21CFR for the Zetasizer? The Malvern Zetasizer is an extremely versatile measurement system. By far the most systems are used in academic and industry research laboratories, for example in fundamental research, drug discovery, or formulation optimization. However, a significant number of installations are in operation in “controlled” environments, such as for quality control in pharmaceutical companies. Here documentation and compliance with good manufacturing standards GMP is critically important, and a specific version of the operating software exist that locks down standard operating procedures (SOP) with limited ability (based on authority) to alter records and procedures, while also keeping extensive audit trails of any alterations of records as well as processes.

What is the 21CFR feature key?

The part number CPS0032 is the special 21CFR ER/ES Feature key that enables the compliant, traceable software mode. Once installed, it allows Security Configuration by the Administrator, audit trail locations etc. For example, a good document describing these options and benefits in great detail is the 21CFR Part 11 – User Guide. Note, it is highly advisable to first check the software update notification for the specific software version. For instance, the latest v7.12 has extensive suggestions for the suggested Windows security setup prior to installing 21CFR. (see pages 10-13 of Software-Update-Notification-for-DTS-v712_tcm22-33123 as it relates to securing specific data directories and folders).

What is ER/ES?

As part of the 21CFR features, the electronic record / electronic signature option allows for digitally signing documents from within the software. In addition, there is also a specific compliance guide for the Zetasizer software. that may be of use in understanding the features and benefits of the feature key.

What is a 21CFR test schedule?

Most likely, when your system includes the 21CFR software, it was also IQ/OQ’d as part of the installation by a Malvern service engineer. This would typically have been ordered with the original setup [SER020007 Bronze Level Service Zetasizer, in case you’d like to know]. You may have an internal validation group that may ask for proof or validation of the features for internal documentation and assurance purposes. Malvern has a test schedule listing many meticulous steps to confirm compliance with the specific requirements of the 21 CFR features. The test schedule CFR2001 is essentially a test of the 21 CFR features on your system with your security. Just to be clear, it is not required to have this test schedule to install the 21 CFR features. It just provides extra validation documentation and may also serve as a good tutorial for customers on how our 21 CFR features work.

So, there are three potential answers to the inquiry from your validation group

Three validation group scenarios for 21CFR
  1. You trust Malvern that the features are compliant. Malvern is a global company with ISO certification, and we have our doors open to external auditors if needed.
  2. You prefer to have documentation at your site that your configuration is compliant. You can purchase the test schedule CFR2001 and it is designed to be a self-test. Going through all the steps will take 1 -2 days and you can have a staff member of your validation team perform the step-by-step testing.
  3. You prefer to have the documentation of the testing of your installation on site and purchase the test schedule CFR2001, and you ask for a qualified Malvern service engineer to go through the tests and document every step. Since this is quite a time intensive, the engineer would be on an hourly rate. And this is an additional service to any standard installation visit.

Hope the above eliminated some confusion about the special electronic signature mode of the Zetasizer software!


If you have any questions, please email me at ulf.nobbmann@malvern.com. Thanks! While opinions are generally those of the author. But our editorial team may have modified some parts.