Computerized systems are used extensively to capture, analyze, store data, report information and to control equipment and processes in life sciences industry at laboratories and manufacturing facilities. Internal and external audit of pharmaceutical and biopharmaceutical industry has consistently indicated a lack of validated computer control and Data Integrity (DI) in the industry.

DI of the computerized systems has become one of the key areas of strong emphasis for regulatory agencies such as Food and Drug Administration (FDA-US), and EU.

_{^{Who Should Attend}}

• QA/QC Production
• Validation
• Engineering
• Audit
• Documentation
• Training
• Technical Support
• Maintenance

^_Outlines

• Background and introduction to Data Integrity
• Introduction to the Data Life cycle model
• Computerized System Validation and DI Fundamentals
• GAMP with DI Requirements
• Industry Regulations and Guidance (FDA and EU)
• What documentation is necessary?
• What are steps you should take to ensure data integrity
• Practical DI Strategies
• 21 CFR Part 11 ER and ES
• MHRA Data Integrity
• FDA Warning-Letters