Memorandum of Meeting Date: August 24, 2001 Site: 1350 Piccard Dr., Rockville, MD 20850 Firm: Sartorius, Inc., 131 Heartland Dr., Edgewood, NY 11717 Participants, Sartorius, Inc: Dr. Oscar-Werner Reif, Director, Research and Development Ms. Denise E. Schettino, Product Manager, Bioprocess Mr. Juergen van den Boogaard, Technical Coordinator Dr. Reinhard Baumfalk, Head of Test Systems Development Participants, FDA: Charles Ahn, Consumer Safety Officer, Office of Regulatory Affairs, Office of Regional Operations Tom M. Chin, CSO, ORA, Office of Enforcement Rick Friedman, CSO, Center for Drug Evaluation and Research, Div. Med. Product Quality Mark Hackman, CSO, Center for Food Safety and Applied Nutrition, Office of Field Programs Paul Motise, CSO, ORA, Office of Enforcement Charles Snipes, Compliance Officer, CDER, Div. of Scientific Investigations The meeting was convened at the request of Sartorius, Inc., to discuss the firm's approach to access and electronic record keeping system features used in an apparatus to determine filter integrity. The visitors were advised that discussions at this meeting may not be construed as FDA endorsement of the design, use of the product, or the product complies with the regulations. The visitors described the system and controls for system administration, user accounts, restricting access, closed system conditions, setting test parameters, secured time stamped audit trails for electronic records within the firm's stand alone device (not for files stored externally to the device), electronic signature display, reporting, providing FDA with suitable electronic copies of electronic records, method in use to ensure copy accuracy, and retention of test result electronic records. The visitors did not distribute any handouts. Prepared by: Tom M. Chin Cc FDA Attendees Part 11 Dockets: Validation 00D-1538 Glossary 00D-1543 Archiving 00D-1539 Time stamps 00D-1542 E-copies 00D-1540 Audit trails 00D-1541 HFC-230 (r/f, chron, File: Electronic Records-Electronic Signatures) HFA-224 Draft: Tchin: SartoriusMOM.doc Edit: Pmotise 8/30/2001; Tchin 9/20/2001 Final: Tchin 9/20/2001 SartoriusMOM.doc August 24, 2001 - Sartorius, Inc., Edgewood, NY Page 2