THE ASSURANCE OF GENUINE QUALIFICATION
Maintaining compliant, controlled facilities is critical to adhering to key regulatory requirements. Our facility and equipment qualification, cleanroom testing, and environmental monitoring service offerings are designed to comply with multiple industry standards, consolidate support, and minimize downtime or interruptions.
Backed by decades of laboratory and CDMO management experience, we understand the pressures of live environments and the need for qualification work that fits seamlessly into ongoing operations. Our support helps achieve compliance at any stage, including new facilities, shutdowns, or ongoing manufacturing.
Our services include:
- Facility validation and equipment qualification: Comprehensive qualification services that support compliant operations across multiple industry standards.
- Cleanroom certification and testing: Flexible testing aligned with USP <797>, cGMP, IEST, and ISO requirements for new and existing facilities.
- Environmental monitoring: Ongoing and project-based monitoring to demonstrate control across new builds, and live operations. Identification of viable and non-viable contaminants in air and surface for controlled settings.
