Computerised Systems Validation
Computerised Systems Validation
Quality is the most crucial requirement in all life sciences industries. Ingredients and products for commercial or clinical trial use must be produced, stored and distributed with the utmost care and quality, and computerised systems are becoming essential for these processes.
Computerised systems that control, monitor, and document production processes, or are used in supporting processes such as electronic quality management systems, training records, ERP, building management / security or laboratory testing, need to be considered for validation. Computerised systems can include network infrastructure, process control systems and IT type systems.
Capabilities Expertise
- Full lifecycle validation of computerised systems and equipment
- Requirements management
- Gap assessments and remediation planning to ensure regulatory readiness
- Third party suppliers audits
- Data integrity focussed approach
- SOP development and user training
- Development and execution of validation protocols and test scripts
- Risk-based validation strategies aligned with GAMP and industry best practice
- Ongoing system maintenance, support, and revalidation service
Validating computerised systems ensures that all applications function properly and comply with relevant regulatory requirements and guidelines, e.g. FDA 21 CFR part 11, PIC/S Annex 11, FDA 21 CFR 820 and Good Automated Manufacturing Practice (GAMP) 5.
Other Validation Solutions
Synertec’s experience in delivering large scale industrial solutions is supported by our commitment to security, adhering to ISO 27001, Information security, cybersecurity and privacy protection.
Get in touch today to see how Synertec could help with your next project.
