Maintaining Data Integrity And Compliance Of Your Osmometer
Data integrity issues are a leading issue cited in FDA warning letters, mainly due to 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.
Learn about what data integrity is for the pharma and biotech industries, how your analytical instruments can be 21 CFR part 11 and EU Annex 11 compliant for data integrity and electronic record management, and the value of osmolality testing as a key process parameter in the pharma and biotech industries.
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