About The Client
The client was a leading pharmaceutical/biotech company.
Project Overview
Compliance/21 CFR Part 11 needed audit gap remediation. Computer systems being used in the manufacturing and distribution processes needed remediation and validation for CSV/Part 11 compliance requirements.
Benefits & Results
- Reduction in the costs of validation and maintenance in the validated state
- Automated approach to validation
- Risk-based validation
- Computer software assurance
Computerized systems included automated manufacturing equipment, control systems, automated laboratory equipment, laboratory data capture systems, manufacturing execution systems, computer running laboratory, clinical or manufacturing database systems, and interfaces to GMP systems. With our domain experience in manufacturing, research, lab equipment, chemical and biotech processes, Next Generation Sequencing (NGS) pipeline, software systems, and interfaces spanning more than 15 years, United Techno’s capabilities cover the whole range of FDA Compliance needs – 21 CFR Part 11, Part 210/211, GAMP5, Part 320/820, and the entire spectrum of CSV, GMP, GLP, GCP, GDP, GxP, ICH, CQV, equipment, facilities, processes, cleaning, and packaging.