Here’s What We Do
Our equipment qualification process follows industry standards like GAMP, ISPE, and ASTM E2500. We focus on validating critical elements that impact product quality, aligning our activities and documentation with customer specifications, risk levels, and process complexity. This approach ensures full compliance with regulatory requirements while optimizing resource use. By prioritizing high-risk areas and maintaining thorough documentation, we guarantee the reliability and safety of pharmaceutical and biopharmaceutical manufacturing processes, ensuring confidence in the quality of end products in the highly regulated healthcare industry.
Validation Masterplan
Installation Qualification
Operational Qualification
Documentation
Documentation
Process Validation
