Facilities & Equipment Qualification

Facilities and equipment qualification show that manufacturing and laboratory environments meet design intent and remain fit for GMP use. Scope usually includes cleanrooms, process equipment, utility interfaces, and lab systems that affect product quality or data integrity. Qualification is how you prove an asset can support the process before routine production depends on it, and before an inspector asks for the protocol, deviations, and summary report that close the loop.

Viltis supports risk-based qualification programs across facility lifecycle stages: greenfield builds, retrofits, line expansions, and equipment replacement. We help define acceptance criteria from URS and process needs, execute installation and operational checks, and document performance where product contact or critical parameters require it. Requalification triggers are written into the program so the qualified state does not drift after maintenance, relocation, or capacity projects. Drawing and as-built alignment get attention early, because mismatch between P&IDs and the floor is a common inspection friction point.

Qualification is never only a Day-1 event. Facilities change through maintenance, layout shifts, and capacity projects, and equipment is swapped or upgraded under pressure. We help sites define what triggers requalification versus like-for-like verification, and we make sure the quality system can see those decisions. That keeps the qualified state current without turning every filter change into a full protocol rewrite.

Qualification activities commonly include

• Facility and cleanroom qualification planning
• Equipment IQ and OQ aligned to URS
• Critical utility interface verification
• Environmental control system checks
• Requalification and periodic review triggers
• Drawing and P&ID alignment to as-built state
• Inspection-ready protocols and summary reports

Good qualification work reduces surprises on the floor: equipment that meets capacity claims, rooms that hold classification, and records that answer inspector questions without a scramble. Viltis teams work beside site engineering and quality so the package reflects how the facility actually runs, not only how it was drawn. When legacy equipment lacks a clean history, we help reconstruct a defensible approach that quality can accept and operations can maintain. Whether you are qualifying a new suite or cleaning up legacy equipment files, we keep the work tied to how the area will be used and inspected.