Lab Systems Validation - Special Requirements

The FDA expects regulated laboratories to ensure their systems are reliable and perform as designed.  Validating Lab Informatics systems present unique challenges, challenges that add to the existing challenges of validating other information systems. What additional skills are required to validate laboratory systems versus other types of regulated business systems?

In one hour, you will learn about experiences in laboratory systems validation from a variety of case studies and the skill requirements for validating laboratory systems. Join us as we discuss unique aspects of laboratory systems validation and learn how risk-based validation makes a difference in validation approaches. Learn how other companies have overcome the pain of insufficient expertise and have experienced the benefits of having the correct capabilities available to effectively complete their validations.

Key Takeaways:

• Learn the various categories of laboratory systems that typically require validation
• See how laboratory systems differ from other types of systems
• Identify 3 key knowledge areas necessary to ensure properly validated
• Use GAMP 5 to modify validation approaches for greater efficiency
• Develop strategies for increasing skills for validation personnel
• What to consider when approaching the validation of CDS, LIMS, or ELN applications