Computer Application Validation

Computer Application Validation

Interactively 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 experience real-life situations while honing problem-solving skills.

Audience

This course is designed for individuals seeking industry training related to validation work done for computer system applications and personnel responsible for implementing and using regulated computer systems in the biotechnology and biopharmaceutical sector.

Topics Include

This 2 day, 16 hour course covers the following topics:

  • Types of Computer Application Validation
  • GMPs and Regulatory Requirements
  • Industry Guidance Documents and Documentation requirements
  • Risk Assessments and Determining what to test
  • Creating validation documentation
  • Handling discrepancies or deviations during testing

Learning Objectives

Upon successful completion participants will be able to:

  • Understand regulatory requirements related to information systems
  • Assess the levels of validation needed for computer system applications
  • Determine key functions within computer systems
  • Demonstrate proficiency in handling validation deviations
  • Prepare and respond to requirements of validation auditors

Portability

This course may be taught at any location.

Request this Course

Request this Course

Submit this form to request this course to be scheduled.

Computer Application Validation

Level: Advanced

Lecture HoursLab HoursTotal

Instructor Pool

Tim Tice
Related Information
NC Life Science
Video
This video surveys examples of life science-related training provided by NC Community Colleges for... more
Golden LEAF Biomanufacturing Training and Education Center
Video
The Golden LEAF Biomanufacturing Training and Education Center (BTEC) in Raleigh is home to two top... more
BioNetwork Capstone Center
Video
Capstone Center in Raleigh is BioNetwork's premiere worker training facility.  At Capstone,... more
  • <
  • 2 of 2
  •