Published on April 3, 2014
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.
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1. computerized system validation Creator: HuongPT Created: 06 March 2014 2. Agenda Principles to ensure the reliability of computerized systems What is…
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