By Steve Cross on Monday, July 22, 2002 - 02:38 pm:
Hi,
I need to set up a small pharmacetical lab that needs to be GxP and 21 CFR Part 11 compliant. I have been looking at the Runtime21 package from Agilent with 1100 LCs. Does anyone have experience with this package? Is it a turn key compliant solution? We are a small lab and don't have a DBA, agilent says this package was designed for labs just like ours>
By Anonymous on Tuesday, July 23, 2002 - 03:46 pm:
Right, and Airbus just designed a new jet for small airlines that don't have pilots or maintenance personnel.
By chris on Tuesday, July 23, 2002 - 08:50 pm:
A couple of questions and observations:
is your lab going to be GCP, GLP, or GMP compliant? These are all different. It is a mistake to lump them all together. In regard to software compliance, it is important to look around at many different software packages. It is necessary for you to prove the compliance to Part 11. Any promises by the software companies goes nowhere with an FDA inspector. There is NO SUCH THING as a turn-key solution. You will still need to qualify and validate the software, write your part 11 compliance SOP's, etc.
Good luck. Setting up a lab like this is a lot of work, but is also a lot of fun.
By Tom Mizukami on Wednesday, July 24, 2002 - 11:26 am:
One of our other sites is implementing this package and I have taken a look at it.
First, I think the package is a good value for what you get. However, as chris and anon said, what you want does not exist. This package covers about half of what you need.
Oracle is a large and complex program that is DESIGNED to be professionally administered and maintained on enterprise class hardware. These Oracle backed data systems are a good choice for the large pharmaceutical companies with professional DBA resources.
For a small lab Oracle is an unjustifiable burden that is going to decrease the reliability of your records not increase it, which after all is the intent of part 11. There is nothing in part 11 that requires a database.
The runtime21 package does not have hot or cold database backup scripts or a cd or DVD writer to archive your data. There is no coherent backup strategy or disaster recovery plan. Worse is if do this yourself, Agilent won't try and help you, instead they will protest.
Agilent does provide a tape backup using the w2k backup utility but they don't test it anywhere in their "qualification". If you already have 1100's and are committed to deploying this send me an e-mail and I can give you our scripts and an outline of a validation and test plan. Otherwise I recommend you look for a non Oracle solution that meets your needs.