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View Full Version : 21 CFR Part 11 Control of Data Requirements in light of ISO 17025 Mark M. Sweeny 26th November 2007, 01:32 PM How do the ISO 17025 requirements compare to the 21 CFR Part 11 requirements for control of data? Any assistance is very much appreciated. Best regards, Mark Al Rosen 26th November 2007, 02:05 PM How do the ISO 17025 requirements compare to the 21 CFR Part 11 requirements for control of data? Any assistance is very much appreciated. Best regards, Mark21cfr11 is more proscriptive than 17025. Jim Wynne 26th November 2007, 02:21 PM 21cfr11 is more proscriptive than 17025. Did you mean prescriptive? Or does 21cfr11 prohibit more things than 17025? Al Rosen 26th November 2007, 02:35 PM Did you mean prescriptive? Or does 21cfr11 prohibit more things than 17025?You're right, that should have been prescriptive. Mark M. Sweeny 26th November 2007, 03:10 PM Thank you for the feedback. One more quick question. For ISO 17025, are control of data requirements limited to Section 5.4.7 or should I be looking elsewhere? Thanks, Mark BradM 26th November 2007, 04:30 PM I may be wrong, but I believe 21 CFR Part 11 deals with electronic records/ electronic data. This is a much broader, much more comprehensive approach to data security, validation, type of software used, etc. Are you having to satisfy both requirements, or are you looking at satisfying one or the other? Do you work in an FDA regulated environment? Mark M. Sweeny 26th November 2007, 08:20 PM We have two different sets of customers. One set requires 21 CFR Part 11 funtionality. The other set requires ISO 17025 record control funtionality. I am familiar with the Part 11 requirements but I am not familiar with the 17025 requirements. I did a quick scan of 17025. My game plan is to compare Section 5.4.7 of 17025 with 21 CFR Part 11. Does that sound reasonsable? Thanks you, Mark Hershal 26th November 2007, 09:21 PM In ANS/ISO/IEC 17025, there are FOUR spots that address control of electronic data and the necessary infrastructure.....all four need to be taken into account..... Specific Clauses: 4.1.5.c; 4.3.1; 4.3.3.4; 4.13.1.4; 4.13.2.3; 5.4.7.1; 5.4.7.2 (a, b, c).....so 4.1.5; 4.3; 4.13; and 5.4.7 are the general sections..... Hope this helps. Mr Niceguy 29th November 2007, 11:14 AM This Eurolab publication that interprets the relevant ISO 17025 clauses might be useful. No. 2/2006 Guidance for the Management of Computers and Software in Laboratories with Reference to ISO/IEC 17025/2005 http://www.eurolab.org/pub/i_pub.html |
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