Commissioning, Qualification & Validation (CQV)

Commissioning, qualification, and validation (CQV) establish that facilities, utilities, and equipment are installed correctly, operate within defined limits, and perform as required for GxP manufacturing and laboratory use. FDA inspections routinely examine IQ, OQ, and PQ packages alongside change control and maintenance records. Viltis helps teams plan CQV so startup timelines stay realistic without skipping the documentation regulators expect to see when they walk the suite.

Commissioning verifies that equipment and utilities work mechanically and electrically before formal qualification begins. Qualification then documents design fit, installation against specifications, operational ranges, and performance under process-like conditions. When commissioning and qualification are sequenced poorly, teams rewrite protocols mid-project and lose schedule. Our consultants help align engineering, quality, and operations on acceptance criteria, sampling plans, and what belongs in commissioning versus GxP qualification so rework stays limited and CAPA volume does not spike after startup.

Lifecycle thinking matters after go-live. Equipment moves, software patches, utility modifications, and preventive maintenance all affect the qualified state. Linked SOPs for change control, calibration, and requalification keep the package inspection-ready years later, not only at startup. We support protocol development, execution oversight, and report writing that ties results back to approved specifications, risk assessments, and the site's quality system language used in management review.

Viltis provides CQV consulting and field resources; we do not issue regulatory certificates or act as an accredited certification body for equipment, utilities, or facilities. Work is scoped carefully to your facility type, product risk profile, and existing quality system so documentation matches how the site will actually run day to day under SOP control, training, and management review expectations.

Typical CQV activities include

• Commissioning planning integrated with project and quality timelines
• IQ, OQ, and PQ protocol development and execution support
• Facility, utility, and equipment qualification packages
• Cleanroom and critical utility qualification coordination
• Change control and requalification after modifications
• CQV documentation assembly for FDA and client audits

If you are bringing a new suite online or recovering from incomplete startup records, structured CQV reduces rework and inspection risk. Talk with Viltis about where qualification support would most improve readiness at your manufacturing or laboratory site before the next client audit or FDA inspection window.