Computer system validation is an approved process that has been mandatory by regulatory agencies across the world. It is the procedure to authenticate that this Computerised System is exactly what it is designed for in a reliable and reproducible manner. These regulatory organizations require the process of Computer system validation to confirm the accuracy and reliability of data in order to ensure product safety and effectiveness. The FDA requires pharmaceutical companies to perform Computer system validation for systems that help in supporting the production of the following products.
- Pharmaceutical companies
- Biological companies
- Medical devices companies
- Blood components
- Human cell and tissue products
CSV is obligatory when configuring a new system or makes any changes in a validated system. It is a process that is based on applicable regulations and guidance. The best characteristic of this system is being validated and allowing the best practices for a domain. This article highlighted the best practice recommendations for Computerised System Validation for effective risk-based assessment and testing.
Computerized System Validation activities should be documented in the following:
- System inventory & assessment
- User requirement specifications
- Functional requirement specifications
- Validation plan & risk assessment
- Network & Infrastructure qualification
- Installation qualification
- Operational qualification
- Performance qualification
- Validation report
- System release documentation
The Best Practices for CSV
- Develop Clear Functional & User Requirements: It is one of the biggest mistakes of companies when starting informatics projects without any strategic planning to ensure success. The initial step in the lab for informatics projects should always undergo workflow & business analysis. The whole process allows the development of clear functional and user requirements and is tailored into a unique operating environment. Without any clear necessities, CSV is not able to prove that the system is functioning properly.
- Execute Risk-based CSV: This process takes a lot of time to accomplish. It is wise to follow a flexible Computerised System Validation to utilize a risk-based assessment on the system. It affects quality assurance and regulatory compliance. The benefits of risk-based CSV are reducing cost, business risk, and duration of the validation.
- Construct a Good Validation Plan: CSV process is guided by a good plan and created before the project starts. This plan has defined the objectives of validation for maintaining its status and satisfies all regulatory policies and industry best practices. It has been created by an expert who has good knowledge of the technology and minimizes the impact on the project on daily basis laboratory processes.
The Bottom Line
Risk-based validation of CSV is playing an essential role in maintaining regulatory compliance and product quality. World Compliance Seminars is an online platform that manages Complaints Handling Training Courses online easily. If you are looking for successful regulatory inspections and audits then World Compliance Seminars is the best platform. Have a deep look into to know them better click on the webpage https://worldcomplianceseminars.com to get all the info you require.
