Validation
Our Validation Capabilities
Synertec’s extensive experience, knowledge and understanding of regulatory requirements has been gained across close to 30 years of our teams executing projects in the life sciences industries, as well as individual experiences as engineering / production / QA personnel within production and laboratory environments. Synertec has assisted many clients to achieve and maintain compliance of their facilities, equipment, systems and processes.
Synertec’s areas of expertise include:
- Development of site validation systems including policies, procedures and forms
- Project validation planning
- Requirements gathering, specification and lifecycle management
- Development of project specific plans and protocols
- Commissioning and qualification support
- Execution of plans and protocols
- Expert testing services
- Turnkey validation solutions for client / third party engineered projects
- Turnkey validation solutions within Synertec engineered projects
- Audits / reviews
- Gap remediation
- Reporting
- Training
Track Record:
Development and maintenance of compliant quality systems
Continuous improvement planning
Risk assessment and risk management
Change management
Training
Audit readiness inspections and remediation planning/execution
Process mapping
Verification and validation of facilities, equipment, systems, and processes
Design, construction, and qualification of cleanrooms and isolation suites
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.
