RE: CFR 21 Sec. 11
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:kyle.eh...@lsil.com 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: richwo...@tycoint.com [mailto:richwo...@tycoint.com] Sent: Thursday, December 13, 2001 1:10 PM To: keh...@lsil.com 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:keh...@lsil.com] 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:kyle.eh...@lsil.com 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
RE: CFR 21 Sec. 11
Kyle, All of the CFRs are available for free on the web from the U.S. Government. Just go to www.access.gpo.gov/nara/cfr http://www.access.gpo.gov/nara/cfr and you can do a search on CFR 21 and the full text will then be available. Kurt Andrews Compliance Engineer Tracewell Systems, Inc. 567 Enterprise Drive Westerville, Ohio 43081 voice: 614.846.6175 toll free: 800.848.4525 fax: 614.846.7791 http://www.tracewellsystems.com/ http://www.tracewellsystems.com/ -Original Message- From: Ehler, Kyle [mailto:keh...@lsil.com] 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:kyle.eh...@lsil.com mailto:kyle.eh...@lsil.com 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
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:kyle.eh...@lsil.com 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
