ABSTRACT

Access Management, Big Data, Cloud Environments, E-Records Integrity, Internet of Things (Iot), SLAs, and Wireless are areas in e-compliance that are under the scrutiny of the regulated user and regulatory agencies attention. Since maintaining data integrity is a primary objective of the CGMP principles, it is important that everyone associated with a computer system is aware of the necessity for the related security considerations. Security controls must be established for all computer systems as a mean of ensuring e-records protection. Computer security is the principal enabler to create the integrity of e-records. Big Data is the process of collecting large amounts of data and immediate analysis to find hidden information, recurring patterns, new correlations, and so on. The e-records controls ensure that the data in the warehouse repositories, extracted raw data, transformed data, and loaded data are managed only by the relevant approved controls and/or validated software applications under a controlled infrastructure.