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Roles, privileges and configuration Empower

Posted: Wed Apr 14, 2021 4:05 pm
by Kina83
Hi! in my company we are going to configure the roles and users in empower3 fr2. I work in the quality control department and I would like to know your experiences.
we have doubts about how to release processing or reporting methods or instruments methods. For example, if the retention time changes, who changes the processing method, the analyst or the chemist or the administrator? Being in quality control we need a double signature ... the same for the instrument method and the report method..
We know that in some laboratories they have a production environment and a validation environment, is this common in quality control labs?
What privileges does the analyst, chemist, method editor or administrator have?
Anyway, just to get an idea of how chromatographic data system are configured in other companies...
Thank you in advance!

Re: Roles, privileges and configuration Empower

Posted: Wed Apr 14, 2021 6:48 pm
by EmpowersBane
There are as many ways to assign priveleges and user groups as there are functions in Empower! Every company is different in how they assign user types to Empower users and it very much depends on how often and for what purpose Empower is used.
In reasonably large labs, its advisable to only have 1-2 users assigned as Administrator and for these users not to be involved in acquiring or processing/data due to obvious concerns about tampering with policies and tweaking or deleting results. These folks should primarily be implementing agreed policy changes/password reset/adding or removing users and archiving or restoring projects.
The next level could assign 2 user types per user, set up in User properties. A primary type which allows creation of projects and custom fields and deleting methods. Deleting results should never be allowed under any circumstances even from Admin. A second type could apply for most day to day users and allow creation of all methods, acquiring data, alter samples and batch process or manually generate results. Its always worth adding full audit trail to every project and system audit trail, this easily captures the who, where, when and what of all activities within Empower. Free form comments should be allowed to explain clearly the reason behind any method update or reprocessing. These comments remain linked to the data channels making audit trail reviews smoother.
I dont agree with tying down the processing method priveleges into allowing either/or the integration, retention time changes etc. Unless you are running the same single molecule which never deviates from month to month, open up all the features to allow the analysts free to integrate or adjust rt windows as appropriate to best integrate and generate the data.
A low amount of priveleges could be assigned to a User Group consisting of QA or data reviewers who check audit trails and provide a final sign off and locking data channels. For example a Data Review type may have the Result Sign Off 2 but not Sign Off 1 privelege, which allows for the analyst to Sign1 and final reviewer to Sign 2. This User Type could have the lock/unlock channels and View Filter Editor privileges to assist their review, but have all data acquisition and saving of results priveleges turned off to prevent accidental result generation.
As i said, this is only an example. Depending on the amount of lab workers, checkers, number of systems and whether the environment is a GMP regulatory controlled lab or pure development, these priveleges completely depend on the company or college.