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United States (Key Regulator: FDA)

US Food and Drug Administration (FDA) established 21CFRPart 11 - regulations on electronic records and electronic signatures. 21CFRPart11 applies to life science industries that fall under Federal Food, Drug, and Cosmetic Act, Public Health Service Act, or any FDA regulation other than Part 11. Collectively those are identified as “Predicate Rules”. In essence, Part 11 applies when the record in question is predicated. 

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Data Integrity & United States FDA:

The regulators around the world continue to look at the data integrity issues/concerns at life science industries. FDA published guidance on data integrity to provide clarity to life science organizations so that the issues/concerns can be proactively addressed.

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United Kingdom

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United Kingdom (Key Regulator: MHRA)

MHRA continues to give greater focus on data integrity. The increasing use of electronic data capture, automation of systems, and use of remote technologies have increased the complexity of supply chains and ways of working – which includes use of third party suppliers. MHRA published the Data Integrity guidance specifically to provide greater clarity and setting expectations to the Life Science Industries to ensure data integrity compliance.  

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Europe

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Europe (Key Regulator: EMA) – applies to member states of the European Union

The European Union Annex 11 – applies to all forms of computerized systems used as part of GMP (Good Manufacturing Practice) regulated activities.  

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Data Integrity & EMA:

Data Integrity continues to be an important topic worldwide. EMA- European Medicines Agency have published a new Manufacturing guidance (GMP) to ensure data integrity that covers the data related to the data generated in the process of testing, manufacturing, packaging, distribution and monitoring of medicines. 

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