Chromatography Forum

Hi ,

How do you control instrument methods in lab ?
Privilege levels and lock method ?
Only admin can create these ?

What about method development and MV robustness (+- changes)

GC_HS you need to input vial number each into method (so will change)
GC front/back inlet/detector may need to be configured depending on system used

Assume HP1100/1200/1260/1290 system can use the same locked method ?
UV, sample tray configuration to consider ?

Input much appreciated

Just don't lock any methods...

For instance, I use a lot of instrument methods for GC, HPLC and UPLC, with different detectors and settings etc. So if I need to change my wavelength resolution from 4.8 to 2.4 etc or add channels, change temperature, as long as you have Full Audit Trail enabled in your Empower system policies, you have to provide a comment when making each change. This comment is visible in the audit trail connected to that method.

You can always see what method parameters are connected to each run, so if any changes occur between runs, they can be viewed under method properties. If you want to go deeper you can "View Differences" between two versions of a method to show an auditor exactly what was changed (but the "why" it was changed should be an audit friendly answer!).

I can kind of understand locking down instrument methods in a highly regulated QC lab with one active peak that doesn't ever change Retention Time or Assay from one end of the year to the other but locking processing methods is madness in my view- stability samples stored at different timepoints and temperatures are extremely prone to variable behaviour in terms of peak shape, degradation profiles etc and the analyst needs the freedom to use any and all of the Empower features to aid integration of the sample at hand.

Hi ,

thanks for your reply
I could not agree more

I am not sure where the locking of instrument methods has come from or under who's 'recommendation' to do this

If this is undertaken then multiple methods for each HPLC, GC will be required for each system configuration


Anybody else locking instrument methods in GMP environment?
What advantages/disadvantages in this process ?

Thanks

It is crucial to have a well-defined method management system in place in the lab to ensure that the instrument methods are appropriately controlled, validated, and optimized for performance. bitlife

User Groups is the key.
Empower admins can assign access of instruments and projects to specific user groups.
If a user is not in the right group, they can't see unassigned instruments, projects or contents of those projects (unless a user who is a member of multiple groups starts copying things around).