CQV services that build a record you can stand behind.
Commissioning, qualification, and validation is one of the most technically demanding and documentation-intensive activities in a life sciences operation. When it is done well, it creates a defensible record that holds up under regulatory scrutiny and gives your team confidence in every system it runs. When it is done poorly, the gaps do not stay invisible. They surface during inspections, deviations, and audits, at the worst possible time.
What we do
Krieger manages CQV programs across life sciences organizations. Our scope covers the full program: Validation Master Plans, URS development, commissioning planning and execution, Installation Qualification, Operational Qualification, and Performance Qualification across equipment, utilities, facilities, and systems. We also support temperature mapping and controlled temperature unit qualification for refrigerators, freezers, incubators, walk-ins, warehouses, and other controlled environments. Change control, deviation management, and requalification for modified or relocated equipment are included where needed. Every deliverable is documentation-complete and audit-ready from day one.
Why it matters
Equipment and systems that are not properly qualified create ongoing compliance exposure that does not resolve itself. A gap in the qualification record sits in your quality system until something forces it into the open. Retrospective qualification is possible but it is expensive, disruptive, and always harder to defend than getting it right the first time. A well-structured CQV program is not overhead. It is the foundation that every other compliance activity in your operation depends on.
How we engage
Krieger can be engaged at any point in the process. Bringing us in during design review allows us to shape the qualification strategy before the first piece of equipment arrives, which reduces rework and documentation burden downstream. We also execute specific protocols for systems already in place, and support periodic requalification programs for equipment that has been modified, relocated, or has reached its review interval.
