Helping customers ensure that newly established computer systems meet GAMP5 standards and are developed in a structured lifecycle approach. We have developed a series of processes and services that are compliant with cGMP/GLP/GCP/GDP/GSP/GEP and 21 CFR Part 11 to ensure the execution, specification, design, programming, testing, and installation of computer systems throughout development and/or requirements. And the quality of the receiving process. Typical computer system certification activities and documentation include:
- Establish user total demand
- Organize preliminary wind assessment
- Establish a quality behavior plan
- System impact assessment
- Verify the master plan / verification plan
- User requirements description
- Function description
- Risk assessment
- Traceability Matrix
- Hardware Design Description
- Software Design Description
- DQ, IQ, OQ, PQ solutions and implementation
- Verification report
