Process validation involves collecting and evaluating data from the design stage through to production, providing scientific evidence that a process consistently yields high-quality products.
At this stage, NioReg organizes meetings with the customer to understand the specific type of validation required.
Our experts carefully plan the time and human resources for each validation, addressing critical factors such as worst-case scenario analysis for samples and the necessary test reports within the validation scope. The results are thoroughly documented and incorporated into the customer's system.
In addition to our standard validation services, NioReg can provide tailored guidance upon request for any specialized process validation needs. Our comprehensive service offerings include:
- Packaging Process Validation
- Cleaning Process Validation (for production and hospital environments)
- Gamma Sterilization Process Validation
- ETO Sterilization Process Validation
- Steam Sterilization Process Validation
- Production Validation (e.g., Injection Molding, Filling, etc.)