Validation Services
IT Systems that are developed or implemented within a highly regulated industry require a compliant Life Cycle Documentation and a system implementation, that consists of well defined Quality Management methods. A typical Life Cycle Documentation consists of the following documents:
- User Requirements
- Functional Specification
- Design Specification
- Design review
- Installation protocoll / Installation Qualification (IQ)
- Functional Qualification / Operational Qualification (OQ)
- Performance Qualification (PQ)
- Risk Assessment
- Traceability matrix
- Defect and Issue management log
BENEFITS
- Secure Systems
- Reliable Data
- Compliance to regulations
- Reduced Risks for inspections
We as LIMSCON can help you with our consultants who have a long experience in Validation Services.
METHODOLOGY
- Valdation is integrated into project plan, phases and milestones
- Paper less Life Cycle Documentation based on HPALM
- Paperless Issue and Defect management
- Risk based testing and validation approach
- Structured documenton that starts from the processes and ends on the validation report
Are you interested?
Please contact us with any questions!