Cleanroom Compliance
At Asgard, our entire team understands the need for cGMP (GxP) compliance and always adhere to the highest regulated standards set out by the various regional and regulatory bodies, such as ISO and the FDA. Our success is strengthened by our total commitment to quality, health and safety and the environment. Asgard Cleanroom Solutions are accredited under I.S. EN ISO 9001:2015 (Quality) and ISO 45001:2018 (Health & Safety).
Our Design Capabilities
- Compare User requirements with supplier specifications
- Supplier assessment
- Verify environment
- Verify arrival as purchased
- Check proper installation of hardware and software
- Test of operational functions
- Performance testing
- Test of security functions
- Test for specified application
- Preventive maintenance
- On-going performance tests
Cleanroom Qualification
Asgard Controlled Environments are fully conversant with the requirements of Design Qualification (DQ), Installation Qualification (IQ) and Operational Qualification (OQ) procedures and the documented evidence requirements to ensure the clients are compliant through the design, installation, and validation process.
Most projects which we are involved with require DQ/IQ/OQ and we have successfully completed these without exception.
Our Qualification Process
1. Design Qualification
2. Installation Qualification
3. Performance Qualification
4. Operational Qualification