Our Services
We provide complete Computer System Validation (CSV) support based on GAMP 5 and global regulatory expectations. Whether you’re validating a new system or revalidating an existing one, we cover all stages — including validation planning, requirement gathering, IQ/OQ/PQ, reporting, and maintenance. Our structured approach ensures compliance while saving time and reducing costs.
Our GxP experts help organizations navigate the complexities of FDA, MHRA, EMA, and WHO compliance requirements. We assess your current systems, identify risks, and implement corrective actions — ensuring that your IT infrastructure meets the highest quality and regulatory standards across Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
We develop complete validation documentation, including Validation Master Plans (VMP), Risk Assessments, User Requirements Specifications (URS), and validation protocols (IQ, OQ, PQ). Our documentation meets industry expectations and is audit-ready, reducing the chances of regulatory observations and delays.
We bring domain-specific validation expertise across Laboratory Information Management Systems (LIMS), Clinical Trial Management Systems (CTMS), Chromatography Data Systems (CDS), and Bio-Sample Management Systems. Our team understands the workflows, risks, and data integrity needs of these platforms — ensuring a smooth, compliant implementation.
We help design and implement Computer System Quality Management Systems tailored for GxP-regulated environments. This includes SOPs, deviation handling, CAPA, change management, audit trails, and training matrices — enabling sustainable compliance and smooth audit readiness.
Compliance doesn’t end after go-live. Our team offers periodic reviews, impact assessments, and controlled change management to ensure your validated systems remain compliant throughout their lifecycle. This proactive support minimizes downtime and regulatory risk.