This document discusses computerized system validation (CSV) and quality assurance principles for ensuring reliable computerized systems. It defines CSV as establishing evidence that a process will consistently produce products meeting specifications. The validation process should be performed during software development and includes master planning, installation qualification, operational qualification, and performance qualification. Quality assurance focuses on processes, while quality control focuses on products. The document also outlines responsibilities for validation, and the software development life cycle of planning, designing, building, testing, deploying, using, and retiring a system.

1. computerized system validation
Creator: HuongPT
Created: 06 March 2014

2. Agenda
 Principles to ensure the reliability of computerized systems
 What is computerized System Validation (CSV) and why is CSV needed
 Responsibilities
 The Validation Process
 Software Development Life Cycle

3. Principles to ensure the reliability of computerized
systems
 What is quality
 What is QC (Quality Control)
 What is QA (Quality Assurance)
 The department's concerns make regulations
 Metrics relating to data quality

4. What is quality?
 Quality is customer satisfaction corresponds to the price that customers
pay
 Customers want quality that is appropriate to the price that they are
prepared to pay and the level of competition in the market

5. What is QC?
 QC is a set of activities for that a manufactured product or performed
service adheres to a defined set of quality criteria or meets the
requirements of the client or customer
 The goal of QC is to identify defects after a product is developed and
before it's released
 QC focus on product

6. What is QA?
 QA Is the systematic process of identifying, planning, implementation and
review of management processes in a company for ensuring quality in the
processes by which products are developed.
 The goal of QA is to improve development and test processes so that
defects do not arise when the product is being developed
 QA focus on process

7. The department's concerns make regulations
 The principles relating to the use of computer systems is "not reduce the
quality of the data, and ensure the quality when paper data is digitized"
And the most worrying aspect of the department's regulations provide:
data quality will be reduced when the data is digitized.
 Why?
. If software has bug then the data will be wrong
. Error caused by incorrect operation
. The damage caused by earthquakes and fires, the data will be destroyed.

8. Metrics relating to data quality
 Attributable
. Data is identified with a specific experience and a specific recorder
 Accurate
. Data is correct and is the latest one.
 Original
. Data is recorded for the first time
 Contemporaneous
. Data is recorded at the time it is generated
 Legible
. Data is readable by humans

9. What is Computerized System Validation (CSV)
 CSV is establishing documented evidence which provides a high degree of
assurance that a specific process will consistently produce a product
meeting its pre-determined specifications and quality attributes

10. Why is validation needed
 Digitized data can be trusted ?
 Computerized sections were serious managed or not ?
 Can receive the quality of work and quality of data with the right investment ?
 Capable of recovering data when there is a disaster ?
 Important data are being protected or not?
 Products can pass the inspection of their company and client company or not
?

11. Why is validation needed
 Reduces risk and legal liability
 Having the evidence that computer systems are correct for their purpose
and operating properly represent a good business practice
 Software is constantly evolving to keep up with the increasingly complex
needs of the people that use it. Therefore validation is an ongoing
necessity

12. Responsibilities
 Computerized system validation must be supported at different levels
within the organization through policies, standards and documentation
. Corporate/Business Unit
. Site/Department Personnel
. Quality Assurance and Regulatory Units
. IT Departments

13. The Validation Process Steps
Validation Process should be performed during the Product Development Life Cycle
 Validation Master Plan
 Installation Qualification
 Operational Qualification
 Performance Qualification

14. Software Development Life Cycle
Planning  Requirement  Design  Build  Test  Deployment  Use
 Retirement

15. Software Development Life Cycle
 Planning phase
The planning phase includes the definition of the intended system,
development of the project plan, and parallel management of the plan
throughout the proceedings.
 Design phase
Documented the detail specifications (the design specification)
 Build phase
Customize, create test plans, deploy data plans
 Test phase
Practice tests (IQ, OQ, PQ), documented results

16. Software Development Life Cycle
 Deployment phase
1. Create SOP, 2. User guide, conduct deploy data for a new system.
 Use phase
Maintaining validation, verification period
 Retirement phase
Create a retired system plan and report.

17. Thank You
ANY QUESTIONS?