computerized system validation

Creator: HuongPT

Created: 06 March 2014

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

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

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

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

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

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.

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

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

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 ?

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

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

The Validation Process Steps

Validation Process should be performed during the Product Development Life Cycle

Validation Master Plan

Installation Qualification

Operational Qualification

Performance Qualification

Software Development Life Cycle

Planning Requirement Design Build Test Deployment Use

Retirement

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

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.

Thank You ANY QUESTIONS?