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

Presented By:
Angela Bazigos - CEO, Touchstone Technologies, Inc.
Speaker Biography:
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Drugs, Biologics, Medical Devices, Healthcare & Food. Experience combines GxP regulations in Quality Assurance, Regulatory Compliance, Clinical Trial Science, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers, Veracyte and other Medical Device Companies & Stanford Hospital.
Co-Presented By:
Kristeena Wright, PhD - Application Scientist, Advanced Instruments
Co-Presented By:
Shweta Nair - Senior Product Manager - Biotechnology, Advanced Instruments
Webinar:
Preserving Data Integrity: 21 CFR Part 11 Compliance and Osmolality as a Process Parameter
Webinar Abstract:
Lack of data integrity is the main reason for most FDA warning letters
In 2017, data integrity issues were cited in 65% of all FDA warning letters. The main reason was 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 re-calls or even the closing of production plants.
Data integrity in the context of 21 CFR part 11/EU Annex 11 & Computer Systems Validation (CSV) Compliance
The US FDA and European Commission have defined the criteria for ensuring trustworthy and reliable electronic records and electronic signatures in computerized systems of regulated pharmaceutical industries. Regulations and standards such as FDA (21 CFR Part 11), EU (Annex 11), GMP, and ISO (ISO 17025) have recognized both the advantages and limits of electronic data systems and have increasingly established further controls for the use of such systems all the way down to bench top instruments. The goals of reducing errors, simplifying processes, and reinforcing compliance can be enabled by compliance with 21 CFR 11/Annex 11 and Computer Systems Validation.
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