Computer Applications Validation

Provides participants with an opportunity to learn and apply requirements in validating Computer System Applications. By concentrating on information systems and instruction on how to meet requirements of CFR 21, Part 11 Electronic Records, Electronic Signatures, the course includes how to test systems security, data integrity, backup and recovery. Hands-on exercises allow students to use validation principles through assessments to determine the level of validation required, writing validation plans, protocols, executing protocols and analyzing results. Case studies and simulated validation deviations allow participants to study real-life situations and learn what to do next in those situations. Also included will be exercises to help prepare students for audits that relate to validation work required for a Compute Systems application.

Primary Audience: Industry
Secondary Audience:
Primary Industry Sector:
Secondary Industry Sector: na
Program Type:
Lecture Hours: 8
Lab Hours: