Computer System Validation Services in London
As the pharmaceutical and biotechnology sectors evolve, stringent regulatory compliance is essential for product safety and efficacy.
Our computer system validation services in London help companies meet these standards while optimising efficiency. We deliver tailored, comprehensive validation solutions, combining industry expertise with a commitment to quality assurance.
Why Computer System Validation (CSV) is Essential for Compliance
Computer System Validation (CSV) is essential in regulated industries like pharmaceuticals, ensuring reliable, accurate system performance to safeguard data integrity, patient safety and regulatory compliance. Adhering to standards like GMP and GDP is crucial, as authorities increasingly analyse electronic system validation.
Our team understands these requirements and offers bespoke validation services to streamline your compliance journey and improve system performance.
Our Comprehensive CSV Services
Our computer system validation services in London cover everything from planning and assessment to documentation and ongoing maintenance, supporting clients throughout the entire validation lifecycle.
CSV Lifecycle Framework Creation
We create a CSV framework tailored to your organisation’s specific needs. This includes developing Standard Operating Procedures (SOPs) and comprehensive documentation such as Validation Plans, User Requirement Specifications (URS), Traceability Matrices, Functional Specifications and Validation Summary Reports.
System-Specific Documentation and Templates
To ensure streamlined processes, we provide customised templates for each step in the validation process. These include templates for Data Migration Plans, Functional Risk Assessments and Performance Qualification (PQ). Our experts can incorporate Failure Mode and Effects Analysis (FMEA) approaches where applicable, further enhancing risk management.
Risk Assessment and Compliance Audits
Our team conducts risk assessments to identify potential compliance gaps. We evaluate existing processes, analyse vulnerabilities and ensure alignment with GMP and GDP requirements. Additionally, we offer desktop audits and a system register to support compliance monitoring and reporting.
Data Migration and System Integration
Transitioning from one system to another or integrating new solutions can introduce significant risks. We manage this process seamlessly, ensuring accurate data migration with a focus on data integrity and validation at every step.
Ongoing Validation and System Maintenance
Computer systems require continuous monitoring to stay compliant as regulatory expectations evolve. We provide ongoing validation support, including periodic reviews and requalification services to keep your systems compliant and audit-ready.
Why Choose Us for Your CSV Needs?
At Inglasia, we are committed to helping our clients in the pharmaceutical and biotechnology sectors achieve operational excellence through validated, compliant systems. Here’s why companies choose us:
Industry Expertise
Our team comprises seasoned professionals with extensive experience in quality assurance, regulatory compliance and CSV in pharmaceutical and biotechnology environments. Our consultants stay informed about regulatory changes, ensuring your systems meet the latest standards.
Tailored, Flexible Solutions
We recognise that every client has unique requirements. Our approach is flexible, allowing us to provide a bespoke solution that fits your company’s specific operational and compliance needs.
Commitment to Quality and Compliance
With a foundation rooted in quality assurance, we uphold rigorous standards in all our services. Our processes are transparent, efficient and aligned with GMP and GDP guidelines, ensuring optimal compliance and performance.
Our Approach to CSV: Structured, Systematic and Compliant
CSV can be complex, but our structured approach simplifies it. We start with a needs assessment to identify compliance gaps and align our strategy with your goals. Our systematic planning, testing and documentation ensure reliable system performance, helping clients avoid costly compliance issues and uphold high-quality standards.
Get in Touch
For quality-focused, compliant and efficient computer system validation services in London, contact us today. Our team provides tailored solutions to ensure your systems are both compliant and optimised for performance.
At Inglasia, we understand the unique challenges faced by pharmaceutical and biotechnology companies. Our CSV services are designed to help you navigate these challenges with confidence, keeping your systems compliant, audit-ready and efficient.