In today’s rapidly evolving technological landscape, pharmaceutical manufacturers are increasingly adopting computerized systems to streamline their operations and enhance quality management. Consequently, Computerized System Validation (CSV) has become an indispensable process for pharmaceutical manufacturers, especially those aiming to achieve EU GMP certification.
However, implementing CSV in Vietnamese pharmaceutical companies often faces challenges such as:
- Upgrading existing legacy systems.
- Integrating software developed by domestic suppliers.
- Lack of technical understanding of systems.
- Shortage of skilled personnel.
- Limited financial resources.
If you’re encountering these challenges, SEN Pharma can help. Our team of experts will provide you with a comprehensive and cost-effective solution.
1. Why Choose SEN Pharma?
SEN Pharma is a partner of FactoryTalk, one of Southeast Asia’s leading CSV service providers with a global reputation.
FactoryTalk boasts a team of experts with over 18 years of experience:
- Advised and supervised by Mr. Anthony Margetts, co-founder and author of GAMP-related articles and guidelines, and Editor-in-Chief of new GAMP editions.
- Speakers at ISPE events in various countries including the global headquarters, Malaysia, India, Thailand, Indonesia, Vietnam, Singapore, and the Philippines.
- Successfully completed over 27 CSV projects.
- Delivered over 100 training programs to 4 national regulatory agencies.
2. Our Solutions for Computerized System Validation
GAP Analysis:
- Assessment of the current state of computerized systems.
- Identification of systems requiring validation.
- Recommendation of necessary actions.
On-site Training:
- Tailored training programs combining theory and practice to enhance understanding of ISPE GAMP 5, CSV, and CSA.
- Develop tailored training programs to each customer’s needs and the current state of the computer system.
Consulting Services:
- Support and guidance on CSV implementation in accordance with regulations such as CFR 21 Part 11, EU GMP Annex 11, CSA (Computer System Assurance), and GAMP.
- Validation of computerized systems, including:
- Providing comprehensive project documentation.
- Developing validation plans, requirements, and criteria.
- Conducting risk assessments.
- Performing testing and reporting.
- Preparing for inspection.
Contact SEN Pharma‘s Fanpage or Zalo (086 918 0917) for immediate support and consultation.
