Managing and controlling e-records is vital for maintaining CGMP data integrity.
Orlando Lopez
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Orlando López is an industry veteran holding several technical and management positions in different pharmaceutical and medical device companies in the areas of computer validation, IT Compliance, and IT Processes. He is a member of the Data Integrity Working Group (Institute of Validation Technology). He can be contacted at olopez6102@msn.com.
Articles by Orlando Lopez
The author reviews key technological expectations of EU GMP inspectors on the integrity of e-records.
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Latest Updated Articles
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