Computer System Validation & Assurance Services
TECHNOLOGY / Applications
SAP ERP, Dell Boomi iPaaS Platform, LIMS, Next Generation Sequencing pipeline, ARGUS Safety, Trackwise, Oracle ERP, MES Systems. etc.
Top Pharmaceutical / Biotech Company
Project Details Or Problem Statement
Compliance/ 21 CFR Part 11 audit gap remediation. Computer systems used in the manufacturing and distribution processes to be remediated and validated for CSV/ Part 11 compliance requirements.
Technology or Business Solution provided by United Techno
United Techno team has provided the full end to end computer system validation services. To mitigate regulatory risk, United Techno offers a broad array of quality compliance and validation services, ranging from risk assessment and hardware/software qualification to full system validation and revalidation.
Our Compliance and Validation Portfolio includes
What is the value addition or benefit realized by client
Benefits realized by clients includes
Computerized systems may include – automated manufacturing equipment, control systems, automated laboratory equipment, laboratory data capture system, manufacturing execution systems, computers running laboratory, clinical or manufacturing database systems, and any interfaces to GMP Systems. United Techno’s Capabilities cover the full range of FDA Compliance needs: 21 CFR Part 11, Part 210/211, GAMP5, Part 320/820, and across the entire spectrum of CSV, GMP, GLP, GCP, GDP, GxP, ICH, CQV, equipment, facilities, process, cleaning, packaging.
Our Principal consultants have more than 15 years of life sciences and Pharmaceutical experience. We have Subject matter expertise in manufacturing, Research, Lab equipment’s, chemical & biotech processes, Next Generation Sequencing (NGS) pipeline, Software systems and Interfaces.