A Scalable Version Control System for Janus Program Files To Meet Regulatory Requirements and Ensure Program Integrity

We have designed a scalable and automated version control system for PerkinElmer Janus liquid handling programs that prevents users from modifying validated programs and ensures that all instruments in a laboratory carry the latest validated version of each of the laboratory’s programs. The CAP Laboratory General Checklist requirement for version control of software that impacts patient results poses a logistical challenge for clinical laboratories that run automated liquid handlers. Unvalidated modifications to any pipetting settings within a program can impact results in unpredictable ways. Given the ease with which end users can modify these settings, laboratories must ensure that modifications to a validated program are caught before the program is used to generate patient results. Even when modifications are validated, laboratories with multiple instruments must implement these changes manually on each instrument, leaving room for error and variability across instruments. Our version control system uses two scripts to address these challenges. The first is a .bat script that pushes .MPT files from a central location to a Janus instrument when a user logs onto that instrument. Each time a new version of a protocol has been validated, it can be dropped into a server folder and pushed to the local drives of all Janus instruments from there, eliminating the need to upload the new version to each robot separately. The second script is a .msl module that compares the date of last modification of the current program against a protected list of the validation dates of all protocols. If the date of last modification does not match the date of the most recent validated version the program aborts, preventing users from running a program that has been inadvertently modified. To install the module, the user adds the .msl script to the beginning of the Janus protocol and edits four lines of code to provide the assay-specific details needed to run the script. When a new program is validated, the user uploads that program to the server folder and updates the protected list with the new validation date to ensure all instruments will run the updated program. A locked copy of the new version should be saved alongside documentation of the modifications made to allow the user to restore the validated version should an unexpected modification be made to the copy in the server location. This system not only ensures compliance with version control requirements, but efficiently scales and automates version control for Janus programs.