Data integrity for computerized systems in GxP environment
The goal of the course
Explore all aspects related to data integrity in the system's lifecycle
Dive deep into data integrity aspects related to computer system validation based on GAMP 5 edition 5 and other guidelines
Gather information about common data integrity findings from the FDA and local regulatory bodies
Scope of the course
Data integrity in system design
Ensuring Data Integrity
Accounts & Access Rights
Data security
Audit Trail
Backup & Restore
Data integrity in system operation
Operational Processes
Periodic Review
User Access Review, Account Usage Review
Audit Trail Review
Data Integrity in System Retirement
Migration
Archival
Destruction (Retention, Destruction)
Data Integrity Assessment
Audit trail
Reporting
Backup and restore
System Security
Data storage and export
Accounts & Access Rights
Data integrity for computerized systems refers to the accuracy, reliability, and consistency of data throughout its lifecycle. It ensures that data is complete, unaltered, and remains intact from the moment it is created or entered into a system until the time it is accessed, modified, or deleted. Maintaining data integrity is crucial for ensuring the trustworthiness and quality of information in computer systems, especially in sectors like healthcare, finance, and regulatory compliance where accurate data is essential for decision-making and compliance with regulations. Various measures, such as encryption, access controls, validation checks, and backup procedures, are employed to preserve data integrity in computerized systems.
Khám phá thêm các khoá học cùng chủ đề
Saurabh Kundgar
Rafat Alghubari
SIA Global Security
MTF Institute of Management, Technology and Finance
Amal Jayasinghe
Governance Risk and Compliance GRC
Dr. Vincent Baeyens
