New Computer System Validation Templates and Procedures Suites

Kymanox is happy to announce our new templates and procedures suites for Computer System Validation (CSV). We have CSV suites for Biotech & Pharma, and one specifically for Medical Devices.

These suites have been developed based on our broad range of experience validating computer systems for both pharmaceutical and medical device companies.

Here's what the Standard CSV package contains:

• Overall Validation Process (20 pages)
• Validation Project Plan Procedure & Template (9 & 10 pages)
• User Requirements Specification Procedure & Template (10 & 8 pages)
• Software Requirements Specification Procedure & Template (19 & 12 pages)
• Risk Assessment Procedure & Template (8 pages & Spreadsheet)
• Software Design Specification Procedure & Template (17 & 11 pages)
• Traceability Analysis Procedure & Template (8 pages & Spreadsheet)
• Design Review Procedure & Template (7 & 4 pages)
• Change Control Procedure & Template (17 & 3 pages)
• Commissioning Protocol Procedure (6 pages)
• Installation, Operational, and Performance Qualification (IQ/OQ/PQ) Procedure & Template (8 & 13 pages)
• Installation Qualification Template (2 pages)
• Operational Qualification Template (2 pages)
• Performance Qualification Template (2 pages)
• Performance Qualification Template (2 pages)
• Installation, Operational, and Performance Qualification (IQ/OQ/PQ) Summary Report Template (5 pages)
• Exception Reporting Procedure & Template (16 & 2 pages)
• Validation Monitoring Procedure & Template (12 & 4 pages)

Here's what the Medical Device CSV package contains:

• Overall Validation Process (20 pages)
• Validation Project Plan Procedure & Template (9 & 10 pages)
• User Requirements Specification Procedure & Template (10 & 8 pages)
• Software Requirements Specification Procedure & Template (19 & 12 pages)
• Part 11 Assessment Procedure (12 pages)
• Risk Assessment Procedure & Template (8 pages & Spreadsheet)
• Software Design Specification Procedure & Template (17 & 11 pages)
• Traceability Analysis Procedure & Template (8 pages & Spreadsheet)
• Design Review Procedure & Template (7 & 4 pages)
• Change Control Procedure & Template (17 & 3 pages)
• Commissioning Protocol Procedure (6 pages)
• Installation, Operational, and Performance Qualification (IQ/OQ/PQ) Procedure & Template (8 & 13 pages)
• Installation Qualification Template (2 pages)
• Operational Qualification Template (2 pages)
• Performance Qualification Template (2 pages)
• Performance Qualification Template (2 pages)
• Installation, Operational, and Performance Qualification (IQ/OQ/PQ) Summary Report Template (5 pages)
• Exception Reporting Procedure & Template (16 & 2 pages)
• Validation Monitoring Procedure & Template (12 & 4 pages)