Equipment and Software Validation
Where process results cannot be fully verified during routine production by inspection and testing, validation of the process must be performed according to established procedures. Process validation assures that the process consistently produces devices that comply with their predetermined specifications. The following processes are among those that should be validated:
- Sterilization processes
- Clean room ambient conditions
- Aseptic filling processes
- Sealing processes for sterile packaging
- Lyophilization process
- Heat treating processes
- Plating processes
- Plastic injection molding processes
Smestad & Associates are experienced in a variety of process and software validations. We can help you perform all phases of the validation process. Our services include preparation of protocols and execution of the validation.
- Installation qualifications
- Operation qualifications
- Performance qualifications
- Sterilization validations (gamma/steam/aseptic process)