Computer System Validation
The US FDA and many international regulatory agencies require validation of computer systems. But, if you don’t know what you’re doing, you can spend a lot of time, money, and effort doing the wrong things. Even if you’re an old pro, sometimes you need an extra hand from an experienced team that is ready to jump in and get the job done.
Our Approach to Computer System Validation
At GxP Validation Services, we customize our validation consulting approach to the areas where you need assistance. For example, if you’re new to computer system validation, we can help you get your policies and procedures in place fast. If you have an important upcoming customer or regulatory agency inspection, we can perform an audit readiness assessment to show you where you’re compliant, where you’re not, and deliver an action plan so you can be ready on time. We also have experienced software validation project managers available to utilize the latest risk-based approaches in leading your in-house validation efforts.
What You Can Expect from Our Consultants
Our computer system validation and software quality consultants have extensive experience in providing leadership to companies seeking to meet regulatory expectations. Here are examples of the types of projects that our consultants perform:
Audit Preparation
- Audit readiness assessments
- Prioritized audit readiness action plans
Computer System Validation
- Validation Program, Procedure, and Template Development
- Automated or semi-automated processes, controlled by a DCS (distributed control system), PLC (programmable logic controller), or similar computer system
- Validation Certification Package Development
- Retrospective Evaluation of Legacy Systems
21 CFR Part 11
- Part 11 Gap Analysis and Remediation Planning
- Part 11 Gap Remediation
- Part 11 Global Compliance Auditing
Software Quality Assurance (SQA)
- SQA Program and Procedure Development
- SQA Auditing
- SQA SDLC Design, Implementation, and Evaluation
- Document Control Process Development
- Change Control and Configuration Management Implementation
Software Testing
- Protocol Development
- Test Script Development
- Test Script Execution
- Testing Review
- Trace matrix verification to ensure testing meets intended use
- Functional Requirements and System Design Specifications
- Test Plan Development and Execution (IQ, OQ, PQ)