Computer Systems Validation
If your business develops Medical Device IP or pharmaceuticals you are likely familiar with FDA regulations regarding validation requirements. Computer System Validation can be time consuming, tying up valuable resources for several weeks. Businesses turn to Engisystems when they would rather focus their limited in-house resources on business-critical initiatives than the time-consuming rigors of addressing regulatory concerns.
Engisystems provides comprehensive Computer Systems Validation (CSV) services encompassing all stages of a computerized system's life cycle. We will work with you to identify, implement and maintain regulatory compliance from deployment through system retirement. Utilizing a risk based approach to CSV, we prioritize and focus on the most critical aspects of the development lifecycle first.
As experts in software validation, we understand the industry leading structured processes for validation of Automated Systems. Our engineers offer extensive backgrounds in the medical device and pharmaceutical markets, understand FDA regulations, and are experts in the tools and templates required to meet regulatory statutes. We continually study and adapt to rapidly changing market trends, ensuring that our engineers are not only current, but have the best resources available.
The diagram below illustrates one of the more commonly used structured processes, the V-Model for Validation of Automated Systems.
Our services include Risk Assessments, Validation Plans, Business/User & Functional Requirements, IQ/OQ/PQ Protocol Analysis and Output Summary Documentation. All items are integrated through a Traceability Matrix established within your existing CSV model. Lean on us to draft requirements, create test cases, and perform all validation and documentation work. Finally, we will integrate the requirements and test cases with businesses proprietary SOP's.
Examples of CSV Services:
- Review of current procedures; development of new processes and procedures to maintain compliance.
- Assessments to determine if the system falls under regulatory oversight and requires validation.
- Risk Management prioritization
- Quality Assurance demonstrating all deliverables are compliant throughout the development lifecycle
- Implementing Problem Resolution or Defect Resolution Processes
- Validation Planning
- Collection of User Requirements
- Development of Functional Requirements
- Design Specifications
- System Construction
- Installation/Operation/Performance Qualifications
- Validation Summary Reports
- Electronic Records and Signatures Compliance