Raleigh North Carolina – Tyson Mew, president of Ofni Systems spoke at QCSV Inc. and the Regulatory Compliance Committee of the Medical Device Cluster Conference on the Proper Use & Validation of Excel Spreadsheets in an FDA Regulated Environments on October 30. The presentation was given in conjunction with Dennis Cantellops, QA Manager for the FDA Office of Regulator Affairs, San Juan District. The FDA Office of Regulator Affairs, San Juan District is implementing ExcelSafe, Ofni Systems’ tool to provide audit trails, user level security, electronic signatures and other technological tools, allowing MS Excel spreadsheets to be compliant with 21 CFR 11.
The presentation started by outlining the FDA’s plans to increase inspectors and inspections, specifically focused on an increased interest in use of spreadsheets in regulated environments. Specific examples of audit observations relating to spreadsheets were discussed. Specific techniques to improve spreadsheet validation were discussed along with a general outline of a spreadsheet validation project.
About Ofni Systems
Ofni Systems is an industry leader for 21 CFR Part 11 compliance. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech and medical device companies across
the globe, while it’s products for computer validation, auditing and FDA submissions ensure that their
clients meet every requirement for electronic records and electronic signatures. The company provides live desktop support for superior customer support and training, and has been providing solutions to their clients since 1999. For more information, call (919) 844-2494 or visit www.OfniSystems.com.
Ofni Systems, Inc.
Phone: (919) 844 – 2494