Data integrity for computerized systems in GxP environment
Explore all aspects related to data integrity in the system lifecycle & computer system validation, GAMP 5
IT and Software ,Other IT and Software,
Lectures -6
Resources -4
Duration -33 mins
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Course Description
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.
Goals
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
Prerequisites
No Prerequisites are requrired
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Curriculum
Check out the detailed breakdown of what’s inside the course
Introduction
2 Lectures
-
Introduction 02:00 02:00
-
Guidelines, Definitions & Regulations 06:21 06:21
Data integrity in system life cycle
3 Lectures
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Data Integrity - Most common findings
1 Lectures
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Instructor Details
Adrian Krzesniak
I am a seasoned Computer System Validation expert with over 15 years of extensive experience. My professional background encompasses a wide range of disciplines, including Information Technology, Software Development, Quality Assurance, and Software Quality Assurance. Throughout my career, I have had the privilege of imparting knowledge to and training hundreds of individuals in various facets of Computer System Validation.
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![apple logo](/market/public/assets/newDesign/img/apple.png)
![armani logo](/market/public/assets/newDesign/img/armani.jpg)
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![capegemini logo](/market/public/assets/newDesign/img/capegemini.png)
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![hdfcbank logo](/market/public/assets/newDesign/img/hdfcbank.png)
![ibm logo](/market/public/assets/newDesign/img/ibm.png)
![intel logo](/market/public/assets/newDesign/img/intel.png)
![mastercard logo](/market/public/assets/newDesign/img/mastercard.png)
![netflix logo](/market/public/assets/newDesign/img/netflix.png)
![qualcomm logo](/market/public/assets/newDesign/img/qualcomm.png)
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