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This course covers the key concepts of Record and Data Integrity and Electronic Records and Signatures, including the key regulatory requirements and expectations (including Annex 11 and Part 11, and related guidance), example citations, and pragmatic industry good practice.
Regulators and Health Agencies are continuously stressing the importance of the topic
Data Integrity is a significant theme in many recent regulatory citations
Record and data integrity are an essential part of the pharmaceutical quality assurance system and essential to operating in compliance with GxP requirements
A secure foundation of data integrity is vital to protect the quality of the product and the safety of the patient
This course will help you understand the requirements and apply practical current industry good practice, to ensure compliance and to manage quality risk.
