A full lab qualified, on time.
Damgaard Solutions built an end-to-end CQV framework for Oxymat in Denmark, qualifying around 14 analytical instruments plus an autoclave and washer to ISO 17025 and ISO 9001, and caught a supplier calibration gap before delivery.
A Heterogeneous Lab With No Formal CQV Baseline
Oxymat manufactures on-site gas generation systems and needed a structured laboratory to support testing, calibration, troubleshooting, cleaning, and release. The portfolio was heterogeneous: around 14 analytical and gas-measurement instruments from multiple manufacturers, each with its own software, calibration dependencies, and documentation conventions, plus an autoclave and a washer-disinfector that needed cycle and load validation beyond standard analytical qualification.
All of it had to be brought under one coherent framework without diluting rigour for any single unit, and aligned to ISO 17025, ISO 9001, and Oxymat's internal QMS. A supplier audit then surfaced a major finding on calibration certificate issuance that had to be resolved before qualification could proceed with confidence, all inside a fixed project timeline.
A Tiered CQV Framework, Audited at the Source
Damgaard Solutions led the full CD/DQ/CQV program as Validation Lead, designing one framework flexible enough to cover analytical instruments and process equipment without losing consistency.
1. A tiered Validation Master Plan
Authored a Validation Master Plan that grouped instruments by functional category and software complexity, so a single set of qualification templates could be adapted per equipment type while keeping acceptance criteria consistent across the lab.
2. Requirements captured from the floor up
Ran workshops with engineering, operations, QA, and end-users to define design intent, then authored the URS and Engineering Specifications for every instrument and managed procurement against those requirements.
3. A supplier audit before delivery
Conducted a formal audit at the primary instrument vendor before equipment shipped. The major finding on calibration certificate issuance was escalated to the supplier's quality director within 48 hours and closed, with agreed corrective actions verified before FAT.
4. Qualification executed on site
Authored and executed IQ, OQ, and PQ protocols across the lab, coordinated Site Acceptance Testing, and recorded all deviations and change controls under Oxymat's QMS, delivering a complete, traceable qualification dossier.
Samsam Touranian is a Validation Lead and CQV specialist at Damgaard Solutions who builds qualification frameworks for complex, mixed-equipment environments. He combines machine and validation engineering with disciplined supplier management, qualifying equipment thoroughly while leaving clients with methodology they can reuse.