21 CFR Part 11 & CSV

We have extensive experience with 21 CFR Part 11 and system compliance, include computer systems validation (CSV) and hardware/network qualification.

Compliant Systems
We have extensive experience validating and applying change management to the following enterprise application systems
1. Oracle Siebel
2. Grand Avenue Software
3. Oracle Argus
4. IRMSWeb
Validation & Qualification
1. Risk assessments and mitigation for vendors, validation, and regulatory compliance for all changes to regulated systems
2. Lead design and building of infrastructure for new and existing systems and completion of Infrastructure Qualification (IQ) for network, servers, switches
3. Lead team in requirements gathering, requirements documentation (URS, FRS), requirements traceability matrix, solution design specification, Design Qualification (DQ)
4. Participate in code reviews, design review for solution, as-built design
5. Create and/or approve test scripts for Operational Qualification (OQ), including dry-runs
6. Approve OQ results and ensure that all issues have been addressed and documented and the system is ready for deployment
7. Approve deployment plan and steps along with the checklist for Performance Qualification (PQ)
8. Approve Validation Summary
10. Ensure all changes are assessed for risk and potential impact on data integrity and security, including change control of data audit sub-systems and multiple levels of application and network security