Preserving Data Integrity: 21 CFR Part 11 Compliance and Osmolality as a Process Parameter

Did you know that data integrity issues were cited in 65% of all FDA warning letters in 2017? The main reason was due to having incomplete data. In the Pharma and Biotech Industries this can be prevented by ensuring the trustworthiness and reliability of electronic records, a process that is also known as Compliance with Data Integrity. The highest risks, when not working in a compliant manner, lie in import bans, product recalls or even the closing of production plants.

Attendees will Learn the Following During this Presentation:

• Explain what data integrity is for pharma and biotech industry.
• Demonstrate how your analytical instruments can be 21 CFR part 11 and EU Annex 11 compliant for data integrity and electronic record management.
• Recognize the value of osmolality testing as a key process parameter in pharma and biotech industry and how it supports 21 CFR part 11 and EU annex 11 regulations.

Related Resources

• Resource Guide: Data and Compliance – What every lab should know
• Bioprocessing Osmometers Selection Guide
• Research Article: Osmolality is a predictor for model-based real time monitoring of concentration in protein chromatography