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Understanding Computer System Validation (CSV) in the Pharmaceutical Industry

What are the different types of validation in the pharmaceutical and medical device industries?2024-01-31T16:25:52+00:00

There are several types of validation in the regulated environment.  These include process validation, analytical method validation, cleaning validation, equipment qualification, computer system validation, and others.

What is validation?2024-02-01T15:59:50+00:00

Validation is documented evidence that a piece of equipment, a system, or process does what it is supposed to do and not what it’s not supposed to do. In Computer System Validation (CSV), this includes ensuring that the system is accurate, reliable, secure, and can consistently produce valid results.

What are IQ, OQ, and PQ?2024-02-01T16:03:23+00:00

IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification) are the three main validation activities that are typically conducted during equipment qualification and CSV. The IQ ensures that the equipment or system has been installed correctly, the OQ verifies that the equipment or system operates in accordance with its specifications, and the PQ ensures that the equipment or system performs as intended in a simulated real-world environment.

Why are IQ, OQ, and PQ needed, and which is the most common?2024-02-01T16:04:29+00:00

All three activities (IQ, OQ, and PQ) are required because only together can they ensure that the equipment or computer system is fully validated and operates correctly in accordance with its intended use. The IQ ensures that the equipment or system has been installed correctly, the OQ verifies that the equipment or system operates according to its specifications, and the PQ ensures that the equipment or system performs as intended in a simulated real-world environment.

What is the relationship between CSV and CRMs and drug sampling systems?2024-02-01T16:06:06+00:00

CSV ensures that Customer Relationship Management systems (CRMs) and other drug sampling systems meet the regulatory requirements and produce accurate and reliable results.  In accordance with the Prescription Drug Marketing Act (PDMA), a drug manufacturer is responsible for tracking its product from manufacture to distribution to licensed practitioners or pharmacies of hospitals or other health care entities. This is the function of the CRM and other drug sampling systems.

What are the differences between SDLC, Change Management, and CSV?2024-02-01T16:07:46+00:00

Software Development Life Cycle (SDLC) is a process used to design, develop, and maintain software. Change management is the process of managing changes to a system to ensure that the changes are completed in a controlled manner and properly implemented. CSV is a subset of change management that focuses specifically on verifying that the changes made to a computer system were complete and that the system operates as intended.

What are the roles of people involved in CSV?2024-02-01T16:08:45+00:00

The roles of people involved in CSV include the system owner, 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.

What are the key documents in CSV?2024-02-01T16:10:26+00:00

In addition to the IQ, OQ, and PQ, there are several other key documents in CSV. These include the validation plan, user requirements specification, functional/design requirements specification, risk assessment, traceability matrix, test plan, test cases, test scripts, and validation report. The risk assessment identifies potential risks and ensures that appropriate controls are in place to mitigate these risks. The risk assessment can help determine the appropriate level of testing for a requirement. The traceability matrix links the requirements, design, and testing to ensure that all requirements are adequately tested and validated.

What is the relationship between quality and validation?2024-02-01T16:11:31+00:00

Validation activities are designed to ensure that processes and systems are in place to produce products that meet the required quality standards. Validation is an important aspect of ensuring the quality of pharmaceutical products and helps to ensure that products are safe, effective, and meet the needs of patients.

Do integrations between computer systems need to be validated?2024-02-01T16:13:16+00:00

Yes, integrations between systems need to be validated to ensure that the integrated system operates correctly and consistently in accordance with the user requirements and design specifications.

Are there requirements for maintaining CSV records?2024-02-01T16:14:49+00:00

System owners are required to maintain documentation that the computerized system was developed, installed, operated, and maintained in a compliant manner. These records should be maintained for at least the life of the system, possibly longer depending on the criticality of the information stored in the system.

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