It may be time to upgrade the entire system to not a only be validated, but
compliant with Part 11. There are numerous software solutions out there can
satisfy both needs. Check with Waters for their most current software
package for Part 11 compliance. Usually these packages are some form of a
network solution for connecting multiple units into a single system. I know
that Agilent offers a similar package that we are installing today. Our
approach is to update the validation package of each system and then
validating the entire "network" to cover ourselves for compliance with the
GMPs and Part 11.
An investment now in a software upgrade and validation of all equipment
under control of one software package may eliminate trouble down the road
with retrospective validation of some units.
Dave Goodlander
-----Original Message-----
From: John Magee [mailto:jemagee1@home.com]
Sent: Tuesday, February 27, 2001 3:30 AM
To: PharmWeb Computer Validation
Subject: Restrospective Evaluation - IQ/OQ/PQ
Our Client currently has 16 independent Waters HPLC systems running
various versions of the Millennium Software system.
We are performing a Gap Analysis on the entire computerized
laboratory systems with the HPLC systems being the focus (as they
make up the bulk of the instrumentation)
For some of these systems they have IQ/OQ/PQ for the instrumentation
and the software. For some they only have part, and for some they
have none.
They want to bring all these systems up to code, so we are suggesting
a retrospective validation project.
The question is:
Can you get IQ/OQ once the system is up and running?
If a history/present function document is produced in combonation
with testing today that indicates proper function under normal and
boundary constratings - can the system be considered validated?
Thanks in advance for your help.
--------------------------------------------
John Magee
jemagee1@home.com
US Data Management
--------------------------------------------
Notice: This message, and any attached file, is intended only for
the use of the individual or entity to which it is addressed, and may
contain information that is privileged, confidential and exempt from
disclosure under applicable law. If the reader of this message is
not the intended recipient, you are hereby notified that any
dissemination, distribution or copying of this communication is
strictly prohibited. If you have received this communication in
error, please notify the sender immediately by reply e-mail and
delete all copies of the original message. Thank you.
|