Validation of regulated software
Software used in administrative and supporting tools by a Medical Device manufacturer that could affect the quality of the end-product or service need to be validated for its intended purpose. This includes software in design tools, complaint handling, document control etc.
We can support you with:
- Validation risk assessment
- Establishing or improving company procedures
- Establishing and executing validation master plan
- Incorporating procedures in overall QMS structure
- Validation templates, protocols, reports etc
- Validation project management support
- Training
Contact me for further information
Robert Ginsberg
Office +46 8 621 01 05 or send me a mail