Data integrity / 21 CFR 11

 21 CFR 11 Compliance for Excel Spreadsheets 

90 Minutes Webinar 

​Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.

A Risk Based Approach to Data Integrity, 21 CFR 11 and Annex 11 Implementation

2 Days In-Person Seminar 

This hands-on course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation, such as: What is Data Integrity and how is it implemented?; How to use Risk Based Assessments to reduce work while still achieving Data Integrity and Compliance?;
Data Integrity Frequently Asked Questions; Validation Master Plan; Risk Based Assessment; SOPs; Infrastructure Requirements; and much more. 

life sciences & healthcare Consulting & Training

​​Touchstone Technologies Silicon Valley