What document do you consider the most difficult - Vote now!

Validation documentation the good the bad and the ugly, in the world of validation there is so much documentation surrounding us each day. Whether it’s a new project, updates or upgrades to an existing project there is no getting away from the fact that we are still a paper heavy environment (Unless you have the Validation Lifecycle automated in some slick new software package – that’s another topic!)

So we have added this poll to get feedback from you our knowledgeable community in relation to the documents you find most frustrating or find difficult to manage.

Please use this thread to leave comments about this poll.

Click here to vote now!

I hate creating a trace matrix. What a pain. I love having one though. I always fight to keep the trace matrix from being approved or considered a GMP document. It is a tool, but should not be required.

Interesting thought, I assumed that the RTM is required in order to ensure all requirements have been tested.

Is it an offical GMP requirement?


Do you use any tools? I’ve used (IBM/Rational) Requisite Pro and (IBM/Telelogic) DOORS and feel, by FAR, ReqPro is superior in usability and reporting. Disclaimer: I don’t work for IBM. In ReqPro, I can slice and dice the trace report any way I want and I prefer working directly in the documents.

P.S. I voted for the validation report. We have to be sooo sensitive in wording it.

P.S. I voted for the validation report. We have to be sooo sensitive in wording it.[/quote]

Agree, sometimes a degree in english helps here!

Using tools would make that so much easier. Nope, no tools, never had them either so I don’t know the joy of them. Summary reports to me, are cake. You are just regurgitating what happen during the validation. Maybe a bit of word smithing to smooth over those deviations.

I’ve gone for URS but in reality any of user needs / supplier response / comparison of the two. Reason? Becuase we’re normally installing the thing before anyone gets round to writing down why we needed it in the first place, or how it’s been designed or built! After that, it’s a doddle - maybe …

Does anyone write a URS before a system/equipment is purchased???

We do that a lot of times, helps to compare vendors during the bidding process. Then after we narrow down bidders, we may update our URS. Or if we learn something during the process, we may change the URS.

Sigh, it would be a wonderful change. By the time I know of a new system, they’ve either already purchased it or are well into contract negotiations.

URS are the most difficult documents for me becuase the “users” really don’t know what they want. Getting them to participate in the process can be painful at best sometimes.

Tamara Beall

I think i’ll start a thread entitled “Best way to generate a URS” and see what happens

As promised

undoubtedly the URS. Usually because the ratio of verbage:specification is about 90:10!!!

TMC’s have been the most difficult for me; especially if it involves manufacturing QC testing stations. Widespread use of XML scripts and specifications databases share a common ground but for some reason never seem to be aligned or updated to present the user the latest changes in spec’s. I hope some day all servers could be local-centric and accessible at least for last minute changes by the corresponding authorities of course.