A question that is coming up frequently at the moment is experiences in validating Q-Pulse version 5. I can provide some supporting documentation to assist you with this but would anyone like to share their practical experiences here.

If there is anything you think would be useful to otgher users or even questions you have yourself  then please post it below.

Thanks,

Alan 

I don't know about other Gael communards, but I have quite enough work to do validating all our other software.

I'm hoping the MHRA will not require validation of "non-production" systems.

I have observed basic good practice by documenting upgrades and changes and retaining Gael's documentation of validation of data migrated from ver 4 to 5 as well as performing very basic validation (record checking etc), but I have no plans to use GMP principles or GAMP methodology (http://www.gampforum.com/) (http://www.pmeasuring.com/particleCounter/pharmaceutical/regulations/GAMP) for validation of Q-Pulse. Life's too short!

Hi Gary,

Hate to be the bearer of bad news but if the proposed amendments to EU GMP Annex 11 are pushed through then it's likely that the MHRA will bring their validation expectations in line with the FDA, i.e. formal IQ, OQ, PQ etc.

All the best,

Martin

Forgot to add that Daniel will be posting an article on these proposed changes in the near future.

Have a look here.

The timetable for the revision of Annex 11 "Computerised Systems" was announced by the European Commission as early as in December 2006. You can read more over at gmp-compliance.org.

Obviously there's no set date for when this comes into force, but I think it's a safe bet that it will happen and my guess it will happen  potentially some time in 2009.

Just to emphasise Martin’s comments:

The MHRA are now catching up with the FDA and times are getting harder for organisations that have never been exposed to this type of scrutiny before.

There are issues now surrounding the use of spreadsheet and how they are used, environmental monitoring system and have they been validated. If you use a computerised system/package in the GxP environment then the MHRA will be looking for a risk based validation prior to initial use.

GAMP 4 or 5 are guidance documents on how to do this but they are not the law (just now), they are there to help you with the process and you can develop your own method of validating your systems.. but ensure that your validation process that has been developed confirms that the computer system has been implemented correctly and that it conforms to the functional specifications derived from the original requirements.

Great post lindsaye - cheers!