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
- 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.
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