Hi Lea, I passed your query on to my partner’s husband, Dr. Alan Muirhead, who is involved in certain types of validations. Here is his reply: Betsy, (somehow the left side of the message was cut off, but I think the intent is clear; if you see something in the original that would be important to know, let me know) Typically, the manufacturer is the only one who would offer to supply a "validation package" for an instrument. That package would include Installation Qualification (IQ) and Operational Qualification (OQ) test scripts. IQ usually is how do you install the system--often checklists of hook this to that, load these files off of that CD, etc, plus confirmations of the environment as appropriate (40 amp supply at 220 volts, 20 tons of air conditioning, ...). OQ is a minimal verification that the system works: run a standard sample, get an expected histogram. Unless some firm has defined a niche of validating these instruments, (and I don't know that end of the market), I wouldn't expect anyone else to offer a canned IQ/OQ package. What the writer is missing is the rest of what is meant by validation. First of all, a canned IQ/OQ package does not provide any sort of end user test (also called performance qualification, or PQ). At the very least, the PQ would have to include method verification for how the user intends to use the instrument. The manufacturer can't do that. Second, the FDA has made it clear that validation begins with a validation plan and a set of end user specifications, before any kind of IQ/OQ/PQ can begin. Producing these formal documents--especially user specs--has not been the usual practice in the lab world, but the Part 11 regulation and the new Guidance on Validation do not make exceptions for labs. The agency's position is that the end user testing must demonstrate that the user requirements have been met, and you can't do that without a requirements spec. Finally, Part 11 compliance depends at least as much on procedures and policies in force at the user site as it does on the technical capabilities of the system. So no one can say if FACSCalibur would be compliant without seeing how it was implemented and used. At best, the manufacturer could say that FACSCalibur has the technical features that would allow a Part 11 compliant installation (e.g., audit trails, secure logins, no deletion of records, electronic signature capabilities). But then it's still up to the purchasing company to be sure that all users have unique IDs, that passwords aren't shared, that the file systems are secure, etc. Hope this helps, Alan If you wish to contact Alan directly, his email is muirhead@voicenet.com <mailto:muirhead@voicenet.com> . ************************************************* Betsy M. Ohlsson-Wilhelm, Ph.D., CEO SciGro, Inc./NorthEast Office Harvard Square Center 124 Mt. Auburn St., Suite 200 N Cambridge, MA 02138-5700 Corporate Phone: 1-617-576-5833 Corporate FAX: 1-617-547-1431 Direct Line: 1-617-536-8464 Home Phone: 1-617-536-8455 E-mail: bmow@scigro.com Web: www.maconsultants.com/scigro.htm ************************** CONFIDENTIALITY NOTICE This e-mail transmission may contain confidential or legally privileged information that is intended only for the individual or entity named in the e-mail address. If you are not the intended recipient, you are hereby notified that any disclosure, copying, distribution, or reliance upon the contents of this e-mail is strictly prohibited. If you have received this e-mail transmission in error, please reply to the sender so that SciGro Inc. can take corrective measures, then please delete the message from your Inbox. Thank you.
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