Complete Compliance Solutions
Validation, calibration, and monitoring form the core of regulated operations, and our CQV services weave them together under one roof. From equipment commissioning through ongoing performance qualification, Ellab’s experts align processes, documentation, and risk management to keep you audit-ready.
Strategic Consulting at Every Stage
Whether you’re designing a new production line or updating legacy systems, our consultants partner with your team to develop risk-based protocols, deliver targeted training, and drive continuous improvement.
Measurable Impact
The result? Rock-solid data integrity, faster regulatory approvals, and zero audit surprises, so you can focus on science, not paperwork.
Strong CQV Foundations
Early Planning & Design Deliverables
Robust CQV begins with strong documentation. We support early-phase design reviews and planning strategies that lay the groundwork for a smooth qualification and operational handover:
Commissioning & Qualification Plans (CQP)
Project Execution Plans (PEP)
Validation Planning Documents (PQP, PPP)
Requirements Traceability Matrices
Asset Induction Support for CMMS
Design Qualification Reviews (DQ)
Johnson & Johnson
I would like to express my appreciation for the quality of your work and for being extremely pleasant to interact with.
Richard L. Tallier
Manager, QA Laboratories, Johnson & Johnson
End-to-End Comissioning, Qualification & Validation Services
Ellab’s CQV services span the entire product life cycle, from initial GMP consulting and design through qualification, continuous process verification, and final decommissioning, while integrating our consulting expertise with best-in-class equipment, software, and calibration solutions.
Life Cycle Pillars
- Design & Development: Risk-based process planning, URS/QBD, early design reviews
- Qualification: IQ/OQ/PQ protocols, mapping studies, and requalification services
- Continuous Process Verification: Ongoing monitoring, deviation investigations & CAPA
- Decommissioning: Impact & risk assessments, book-ending studies, data retention
Equipment Qualification and Validation Services Provided
We offer a full range of validation services required by the life science industry. Our services are designed specifically to support a variety of industry guideline and regulation needs. Our support ranges from the development of templates and protocols, onsite hands-on execution and management of validation projects. The support we provide is flexible and customized in order to meet the diverse industry needs.
Common Equipment Qualifications & Process Validations
- Cold-chain units: Freezers (–150 °C to –20 °C), stability chambers, CO₂ & humidity incubators
- Environmental rooms & warehouses: Walk-in cold rooms, stability rooms, seasonal mapping
- Sterile processing: Autoclaves (gravity & vacuum), SIP, media fill & hold studies
- Lyophilization: Shelf mapping, product characterization
- Process vessels & tanks: Bioreactors, compounding & buffer prep, CIP/SIP systems
- Supporting labs: Shakers, centrifuges, water baths, conductivity & soil-test washers
Start Partnering with Ellab
Selecting the right partner for your compliance journey can be easy. At Ellab, we integrate equipment, knowledge, and services to enhance your compliance throughout various projects and everyday operations.
- Local expertise with global reach that minimizes disruption to your operations
- A single partner for all your compliance requirements: Reducing variables and risks
- One standard, no surprises: Consistent experience across all locations
- Optimal scalability with minimal interference, perfect for shutdown periods
Integrated Technology Ecosystem
Achieve comprehensive compliance and operational excellence with our integrated technology ecosystem connecting advanced monitoring, validation, and calibration solutions for your business.
- TrackSense® wireless data loggers
- EMSuite® 24/7 environmental monitoring
- ValSuite® digital validation software
- Accredited on-site and in-lab calibration services
- Centralized compliance dashboards
