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2. Buytaert-Hoefen, K., 2019. A Harmonized approach to data integrity. BioProcess International April 23, 2019. https://bioprocessintl.com/manufacturing/ information-technology/a-harmonized-approach-to-data-integrity/.
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4. Code of Federal Regulations, 2022. PART 211 - Current good manufacturing practice for finished pharmaceuticals. Accessed on August 23, 2022. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211.
5. Code of Federal Regulations, 2022. Title 21, Part 200.10. Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=200.10.