|
RPN Consulting
provides Computer Systems Validation (CSV) services and 21 CFR
Part 11 solutions for pharmaceutical, biotechnology, and medical
device industries that help meet regulatory compliance
requirements. Our experts in validation master planning,
project management, and cost estimation help clients overcome
common validation problems. As experts in Computer Systems
Validation, clients with constrained resources rely upon RPN
Consulting to apply documented QA and QC procedures that lead to
fast and efficient validation, or to identify gaps with
validation studies that do not meet GMP regulatory requirements,
and to develop implementation plans to cost-effectively bring
these studies into compliance.
Computer
Systems Validation Solutions:
- Validation documents:
Validation Plans, Requirements and Design, Installation
Qualification, Operation Qualification, Performance
Qualification, and Validation Summary Report.
- Outsourcing Services:
short and long term on site support.
- Standard Operational
Procedures development.
- Vendor audit and
Risk-based assessment.
- 21 CFR Part 11
Assessments/Gap Analysis and Remediation
RPN Consulting has an
outstanding reputation in the industry for executing high
quality projects and timely delivery. Our Computer Systems
Validation projects meet stringent FDA regulatory compliance
requirements, are practical and time-tested. Our unique, team
project approach to validation is designed to increase
efficiencies while reduce cost.
Get Started With Us... |
