Computer System Validation Services
In today’s rapidly evolving pharmaceutical and life science industries, maintaining validated computer systems isn’t just about compliance—it’s about ensuring product quality and patient safety. At Inglasia, we deliver comprehensive computer system validation services that help you navigate complex regulatory requirements while optimising your operational efficiency.
Transform Your Validation Strategy
Reduce Compliance Risk: Our validation professionals implement a risk-based approach to identify and mitigate potential compliance gaps before they impact your operations. We ensure your computerised systems meet current GMP/GDP standards and regulatory body requirements.
Save Time and Resources: Our streamlined validation process and pre-built templates help control validation costs while maintaining the highest quality standards. We handle everything from user requirements specification to validation protocols, letting your team focus on core business activities.
Ensure Continuous Compliance: Partner with our subject matter experts for ongoing support, from initial validation strategy through periodic reviews and system maintenance.
Comprehensive Computer System Validation Services
Strategic Validation Planning
- Development of validation master plan aligned with your quality management system
- Creation of risk-based validation strategies
- Configuration management planning
- Resource allocation and validation project scheduling
Documentation & Deliverables
- User requirements specification (URS)
- Configuration specifications
- Installation qualification (IQ) protocols
- Operational qualification (OQ) protocols
- Performance qualification (PQ) protocols
- Validation reports and deliverables
- Audit-style template documentation
Specialised Industry Experience
We provide validation services across diverse systems and environments:
- Complex laboratory environments
- Clinical trials management systems
- Applied Biosystems suite (AccuSEQ, MicroSEQ, QuantStudio 5, SeqStudio)
- Pharmaceutical manufacturing systems
- Quality management software
- Life sciences validation software
- Analysis of failure scenarios
- Impact assessment on product quality
- Compliance with international regulations
- Technical specifications review
- Software quality assurance
- Computerised systems audit support
Why Choose Inglasia for Computer System Validation?
Industry Authority
Our validation professionals bring decades of combined experience in pharmaceutical industries, biotech companies, and life science organizations. We understand the nuanced requirements of regulatory bodies and maintain strong relationships with key industry stakeholders.
Cost-Effective Solutions
We help control validation costs through:
- Efficient resource allocation
- Streamlined validation activities
- Risk-based approach to validation efforts
- Reusable validation deliverables
- Optimised CSV processes
- Dedicated project management
- Technical specifications development
- Quality attributes monitoring
- Validation protocols execution
- Configuration management
- Ongoing system maintenance
Contact Us
Don’t let compliance concerns hold your business back. Contact us now to schedule a free consultation with our validation experts. We’ll review your current systems and provide a customized validation strategy that ensures compliance while maximizing operational efficiency.
Industries We Serve
Pharmaceutical Industries
Medical Device Manufacturers
Biotech Companies
Life Science Organizations
Clinical Research Organizations