Thank You everyone!! I found quite a bit of information on this subject and it was determined that our products are compliant. This is more of a OS and System Administrator file and network security issue than hardware integrity. I think I caused a completion on the sale of 1.5 TB of disk storage products. Not bad for a few minutes work.
Thanks again, Kyle Ehler KCØIQE <mailto:[email protected]> Assistant Design Engineer LSI Logic Storage Systems Div. 3718 N. Rock Road U.S.A. Wichita, Kansas 67226 Ph. 316 636 8657 Fax 316 636 8321 -----Original Message----- From: [email protected] [mailto:[email protected]] Sent: Thursday, December 13, 2001 1:10 PM To: [email protected] Subject: RE: CFR 21 Sec. 11 The CFRs are online at http://www.access.gpo.gov/nara/cfr/cfr-table-search.html -----Original Message----- From: Ehler, Kyle [mailto:[email protected]] Sent: Thursday, December 13, 2001 11:02 AM To: 'PSTC list' Subject: CFR 21 Sec. 11 Could someone explain to me or point in the right direction for what CFR 21 Section 11 requirements in a product (such as a disk storage system) for it to be compliant. I think this is about records and electronic signature authentication and has something to do with the FDA (CPG 7153.17). It would seem to be more of an application feature than a hardware requirement? We are caught ignorant on this one and I dont have a copy of the CFR 21, much less CPG 7153.17 (?!). We have found some info, but our layman understanding doesnt answer the question of what/how to comply. Anybody? Respectfully, Kyle Ehler <mailto:[email protected]> Assistant Design Engineer LSI Logic Storage Systems Div. 3718 N. Rock Road U.S.A. Wichita, Kansas 67226 Ph. 316 636 8657 Fax 316 636 8321
