Computer system validation (CSV) is the process of validating computer systems, software applications, and related equipment to ensure they meet the requirements for their intended use. This includes ensuring that the system is accurate, reliable, secure, and can consistently produce valid results.
IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification) are types of validation activities that are typically conducted during CSV. IQ ensures that the system has been installed correctly, OQ verifies that the system operates according to its specifications, and PQ ensures that the system performs as intended in a simulated real-world environment.
Why are IQ, OQ, and PQ needed, and which is the most common?Kristen Anderson2023-04-29T18:11:50+00:00
All three types of validation activities (IQ, OQ, and PQ) are important in CSV because they help to ensure that the computer system is fully validated and operates correctly in accordance with its intended use. IQ ensures that the system is installed correctly, OQ verifies that the system operates according to its specifications, and PQ ensures that the system performs as intended in a simulated real-world environment.
What is the relationship between CSV and CRMs and drug sampling systems?Kristen Anderson2023-04-29T18:15:15+00:00
CSV is important in the development and maintenance of computerized systems used in the production and distribution of CRMs and drug sampling systems. It ensures that these systems meet the regulatory requirements and produce accurate and reliable results.
What are the differences between SDLC, Change Management, and CSV?Kristen Anderson2023-04-29T18:18:00+00:00
SDLC is a process used to design, develop, and test software. Change management is the process of managing changes to a system to ensure that they are controlled and properly implemented. CSV is a subset of change management that focuses specifically on computer systems validation.
What are the roles of people involved in CSV?Kristen Anderson2023-04-29T18:21:12+00:00
The roles of people involved in CSV include the project manager, validation specialist, business analyst, IT specialist, quality assurance specialist, and others. Each person has a specific responsibility in ensuring that the computer system is validated and meets the regulatory requirements.
There are several key documents in CSV, including the validation plan, user requirements specification, functional requirements specification, design specification, traceability matrix, test plan, test cases, test scripts, validation report, and risk assessment. The traceability matrix links requirements, design, and testing to ensure that all requirements are tested and validated. The risk assessment identifies potential risks and ensures that appropriate controls are in place to mitigate these risks
What is the relationship between quality and validation?Kristen Anderson2023-04-29T18:28:17+00:00
Validation is an important aspect of ensuring the quality of pharmaceutical products. Validation activities are designed to ensure that processes and systems are in place to produce products that meet the required quality standards. Validation helps to ensure that products are safe, effective, and meet the needs of patients.
Do integrations between systems need to be validated?Kristen Anderson2023-04-29T18:31:21+00:00
Yes, there are requirements for maintaining CSV records. Regulatory bodies such as the FDA and EMA require that companies maintain accurate and complete records of all CSV activities. These records must be kept for a specified period of time and must be easily accessible for inspection by regulatory authorities. Additionally, companies must have a robust change control process in place to ensure that any changes made to the computer system are properly documented and validated. This helps to ensure that the system remains in a validated state and that the data generated by the system is accurate and reliable.