What are IQ OQ PQ and why are they critical?
We create all documents necessary for the computer system validation for you or together with you. From the validation plan to the validation report. We have been providing this service to our customers for twenty years - our documents have been used in countless audits. Computer system validation aka CSV enhances the reliability of system, resulting in fewer errors and less risk to process and data integrity.
It is intended to reduce long-term system and project costs by minimizing the cost of maintenance and rework. To achieve such long-term goals, it is necessary to implement processes.
CROs provide drug development services, regulatory and scientific support, and infrastructure and staffing support to provide their clients with the flexibility to supplement their in-house capabilities or to provide a fully outsourced solution.
Becoming ValidatedDuring implementations, biomedion helps customers establish a focused validation methodology that facilitates the adoption of software upgrades while maintaining quality and addressing risk. As a standard part of practice, biomedion supports customers with planning, managing, testing, and preparing for validation. biomedion regularly hosts customer audits upon request.
- Master Validation Plan (MVP)
- Business Requirement Document
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- IQ Scripts and Results
- OQ Scripts and Results
- Trace Matrix (through OQ)
- Validation Summary Report (VSR)
- System Release Memo
- Configuration Specification
- Configuration User Requirement
- Specification (URS)
- User Acceptance Testing (UAT)
- UAT Scripts
- UAT Summary Report
- Trace Matrix (through PQ)