Validation documentation requirements are a major factor in the design and manufacture of automation equipment for the medical device, pharmaceutical and life science industries. Innovative has been generating validation documents for our customers for over twenty years. We also participate in the execution of the documents alongside our customers. Utilizing the latest Good Automated Manufacturing Practice guidelines (GAMP5), Innovative can work with your validation team and validation plans to develop and execute the following:
- Process failure mode effects analysis (PFMEA)
- Traceability Matrix
- Functional Specification
- Hardware Detail Design Specification
- Software Detail Design Specification
- Installation Qualification
- Operational Qualification