From: erich.rapp@altanapharma.com Sent: Tuesday, May 11, 2004 9:00 AM To: fdadockets@oc.fda.gov Subject: Docket No. 2004N-0133: Comments from ALTANA Pharma, Germany Dear Madam/Sir: with respect to the FDA's announcement of a public meeting for discussion of topics part 11 (21 CFR part 11), we have prepared some comments which we submit to you for further consideration: Comments to FDA-HHS Docket No. 2004N-0133 from ALTANA Pharma/Germany (contact: Dr. E. Rapp, Int. Quality Assurance, email: erich.rapp@altanapharma.com) I. Background (First sentence) A definition or further explanation of 'handwritten signatures executed to electronic records' would be useful. IV. Topics for Discussion and Comment A. Part 11 Subpart A General Provisions, pos. 1 It would be useful to add following sentence to §11.1 (b): >This does not apply to e-records that are created to make printouts, if these printouts meet all predicate rules and contain the full information of the e-record. Following print-out, the e-record would not be subject to further processing and could be deleted.< A. Part 11 Subpart A General Provisions, pos. 3 There's a permanent discussion about which e-records apply to Part 11. Further explanations and some examples would be useful. B. Part 11 Subpart B Electronic Records, pos. 1 § 11.10 (h): A risk based approach should be possible for device checks. Devices of computerized systems are recorded in the Installation Qualification. Changes are controlled by change control procedures. If this is a static configuration, device checks are not strongly needed. B. Part 11 Subpart B Electronic Records, (For individual controls) pos. 4 Part 11 should not incorporate configuration and document management. C. Part 11 Subpart C Electronic Signatures We don't see a need to extend §11.10d. D. Additional Questions for Comment Question 3 Products or systems may be selected which meet Part 11 requirements but not business requirements, thus potentially leading to technologically inferior solutions. Question 5 Part 11 should include the demand, that the creation and all changes of e-records is traceable. Risk assessments should define, which records needs to be traced and how, i.e. with an audit trail or by versioning or other means. Question 6 Clarification is missing on which changes/modifications/upgrades of legacy systems, performed after Aug. 20, 1997, would require compliance to Part 11. Our concern is that exempting legacy systems would deter innovation. We therefore would prefer an approach based on risk assessment and/or procedural (vs. technical) considerations. Sincerely yours, Erich Rapp International Quality Assurance ALTANA Pharma AG Byk-Gulden-Str. 2 78467 Konstanz, Germany T +49 (0) 7531 84-1369 F +49 (0) 7531 84-91369 mailto:erich.rapp@altanapharma.com http://www.altanapharma.com ---------------------------------------------------------------------- The information contained in this email is intended solely for the addressee. Access to this email by anyone else is unauthorized. If you are not the intended recipient, any form of disclosure, reproduction, distribution or any action taken or refrained from in reliance on it, is prohibited and may be unlawful. Please notify the sender immediately. The content of this email is not legally binding unless confirmed by letter. Der Inhalt dieser E-Mail ist ausschliesslich fuer den bezeichneten Adressaten bestimmt. Wenn Sie nicht der vorgesehene Adressat dieser E-Mail oder dessen Vertreter sein sollten, so beachten Sie bitte, dass jede Form der Kenntnisnahme, Veroeffentlichung, Vervielfaeltigung oder Weitergabe des Inhalts dieser E-Mail unzulaessig ist. Wir bitten Sie, sich in diesem Fall mit dem Absender der E-Mail in Verbindung zu setzen. Der Inhalt der E-Mail ist nur rechtsverbindlich, wenn er unsererseits durch einen Brief entsprechend bestaetigt wird.