Computer System Validation

Computer System Validation (CSV) software is designed to assist organizations, especially those in regulated industries like pharmaceuticals, biotechnology, and medical devices, in ensuring the compliance and integrity of computerized systems with regulatory requirements. These software solutions help streamline the validation processes for systems that play a critical role in product development, manufacturing, testing, and other regulated activities. Here are some features and functionalities typically associated with ComputerSystem Validation software: 

1. Document Management: 

   - Facilitate the creation, management, and version control of validation-related documents, including protocols, plans, and reports.

2. Validation Planning: 

   - Assist in the development and management of a Validation Master Plan (VMP) outlining the overall validation strategy for computerized systems.

3. Risk Assessment: 

   - Provide tools for conducting risk assessments associated with computerized systems to identify and manage potential risks.

4. Test Script Management: 

   - Manage and execute test scripts and protocols associated with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

5. Audit Trail Monitoring:

   - Monitor and manage audit trails to ensure the integrity of electronic records and compliance with regulatory requirements, including 21 CFR Part 11.

6. Change Control Management:

   - Support change control processes, ensuring that any changes to the computerized system are properly documented, assessed, and validated.

7. Electronic Signature Compliance: 

   - Implement electronic signature functionality in compliance with regulatory requirements, providing authentication and accountability for system users.

8. User Access Controls: 

   - Manage user access to the system, ensuring that only authorized personnel have the appropriate permissions based on their roles.

9. Data Integrity Monitoring: 

   - Monitor and ensure the integrity of data generated and stored by the computerized system, preventing data manipulation or loss.

10. Validation Reporting: 

    - Generate reports and documentation to demonstrate compliance with validation requirements, suitable for regulatory submissions and internal audits.


Citations:

Document Version Control Software| Importance of Version Control in DMS (complianceg.com)

RMP-Risk Management Plan | ISO 14971 Risk Management Plans (complianceg.com)

Data Integrity (DI) Assessment, Remediation and Support Services (complianceg.com)

Location: United States

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