Controls and Automation Validation for Regulatory Compliance
ASG’s validation process for control and automation systems allows us to confirm that the system is operating the way that the project plan describes.
If your company or equipment is regulated by the FDA or a similar governing entity, we will assist you through the formal validation process. All regulated equipment must be accompanied by design specifications that define exactly what is in that piece of equipment and how it will work.
Our Engineers will work with your team to run your equipment through the following test procedures:
- IQ – Installation Qualification
- OQ – Operational Qualification
- PQ – Performance Qualification
ASG will thoroughly document your equipment’s validation process as evidence for regulatory review.
ASG generally acts as an adjunct to your existing engineering resources, especially for those companies that do not have significant software development expertise in a regulated development environment.
Contact ASG with any questions about our Validation process.