Chromatography Forum

I'd like to hear others' opinions on whether to install updates to Waters Empower 2, and the amount of re-validation (if any) that is nescessary.

We are a small company using a validated Empower 2 system that is updated through Feature Release 5. There have since been Service Packs F and G made available, each with their own hotfixes. (From what I can tell, Service Pack G is cumulative and includes Service Pack F.) We do sometimes experience problems in Empower, mainly the crashing of the Review window, which I believe would be improved by the updates.

However, we have never installed any updates, mainly because we don't have any dedicated IT or computer validation resources, and I as the system administrator don't have much experience in knowing the level of re-validation that would be required. Waters' release notes just say to process a set of data before and after the update(s) to show that the results are the same, but is that considered sufficient? What do others in this forum do at their companies?

Thanks in advance for your comments.

Not all Empower service packs are equal. For example, adding FR5 is a major undertaking as it basically requires a reinstallation of Empower on all LAC/Es and servers and should be followed by IQ/OQ.

Minor patches do not require much effort to implement, nor do they generally require requalification (unless your internal SOPs say that they do).

As my dept's system is not yet up to FR 5 (no Windows Vista/7 here yet, so no real need), we are trying to postpone the next major upgrade and make it Empower 3.

If possible, investigate the causes for applet failures - check application event logs for the servers hosting the errant applets, if you have McAfee/Norton etc., check their logs to see if they're interdicting traffic between Empower servers and other servers and/or clients etc. etc. before just blaming it all on lack of patching.

As DR noted, not all SP/FR patches are created equally. FR5 was indeed a major update as it was a new database revision, which in most validated environments would mean a IQ, OQ, PQ, System Suitability, etc.
The Release Notes for the various SPs and FRs will usually contain the blanket statement of follow your own SOP. If there are material changes that have been made within the SP/FR there may be a statement about recommendation of requalification. At a minimum in a standard SP release would probably want to do a verify files (the release notes also list those files i.e. .dll, etc that have been installed or updated), on all nodes (process only and acquisition). Additionally, an IQ,OQ may be performed.

You should also keep your nodes (process only and acquisition) at the same level of Microsoft hot fixes and service packs.