Empower 3 Processing Methods - Required to be locked?

[Rhodium]

We are in the process of implementing Empower 3 in an FDA regulated lab. I was under the impression that the processing methods could remain unlocked due to the fact that many times the integration needs some fine tuning. After reading several recent warning letters citing unlocked processing methods, I hope to gain some insight as to what other labs do in this situation. I would rather keep the processing methods unlocked and have an SOP to follow when a change in the processing method is needed. Thanks for your comments.

[shaun78]

I am going to go out on a limb and guess that the agency concern here is that fit types, reference compounds, RRF values, CConst values, CCalRef values, etc., etc. can all be set in the processing method and have an impact on calculated data, custom fields, etc.

I have used a similar approach for people whom I have consulted for when asked my opinion or what the best practice is with respect to Empower processing methods.

Though I chose not to formally lock the methods, I do, however, control access to the methods through either user account types or the user account forced at the project level. In both instances, a user running the method would not have rights to edit the instrument or processing method if the method has been validated or is comppendial.

However, the user does have the ability to alter analyte retention times and change integration parameters, which should be all they need to modify to get data out.

In these cases only a manager and/or system administrator has the ability to edit instrument methods and change anything in a processing method other than retention times and integration parameters.

[DR]

What those notes about warning letters never include is the reasoning behind the call for locking methods.

Did the inspection uncover integration that was inconsistent, inappropriate or downright indefensible? Were reports rife with manual integrations designed to keep products moving out the door?

My guess is that when inspectors see reasonable, consistent integration, little or no manual integration and justifications for significant changes in processing methods (audit trails on, comments required - AND reviewed), there are no calls for locked methods.

[ydna6969]

Hi ,
Interesting thread
Further thoughts and practices welcome


In my experience locking methods is not viable option. Analysts need to process and evaluate results (isn't that why you hired them for in the first place).
Unless super users/admin are available at any time , Right first time and meeting deadlines will go out the window. If you have a solid data integrity process also not an issue (SOP, training , experts also give support here)

All in audit trial as well for reference.

Instrument methods : Possibly lock ? up for debate (how to purge/prime system , equilibrate column , increase flow rate)?

Report : admin/super user usually ? though access for others to learn and gain report creation knowledge/custom fields test ?

Please share thoughts