Case Study

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.

Client Details

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

  1. Document Management Systems - Store, manage and publish quality documentation (e.g. SOPs, validation documentation, etc.) in accordance with GxP regulations.
    1. Implementation Services
    2. Validation and Change Control Services
  2. Exception Handling and CAPA Management
    1. Manage and Support handling of exceptions, deviations, complaints, audit findings, etc.
    2. Manage and support registration and monitoring of corrective and preventive actions
  3. Training Management - Support and Validation Services
  4. Change Management Systems – Validation and Maintenance
  5. Enterprise Compliance


What is the value addition or benefit realized by client

Benefits realized by clients includes

  • Reduced cost of validation and maintenance in validated state
  • Automation approach to Validation
  • Risk based validation
  • Computer Software Assurance

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.