Performance proven: commissioning & validation excellence.
Performance proven: commissioning & validation excellence.
Bridging the gap to production
In mission-critical environments, the "deliver" phase concludes with the rigorous proof that all systems perform exactly as designed. The transition from a finished build to a production-ready environment is the most critical stage of any life sciences project. Without flawless execution of IQ, OQ, and PQ, a facility cannot receive the necessary regulatory licenses to operate. The challenge lies in coordinating complex technical tests (such as airflow visualisation and pressure cascade balancing) while maintaining a strict "paper trail" for audit purposes. Any failure in this phase results in delayed product launches and significant financial impact.
Technical certainty through CQV integration
Equans Sci-tech provides a unified CQV approach that ensures your facility is ready for production startup. Because our validation team has been involved since the design phase, the final commissioning is an exercise in verification rather than discovery. We manage all site acceptance testing (SAT) and environmental monitoring protocols, providing single-source accountability for the facility’s performance. This ensures a rapid, successful handover and total confidence in your regulatory standing.
We execute the final verification of your mission-critical environment, ensuring it is technically robust and audit-ready.
- Installation & operational qualification (IQ/OQ)Rigorous on-site testing to prove that systems are installed correctly and operate precisely according to the design specifications.
- Performance qualification (PQ) supportAssisting your team in proving that the facility performs consistently under real-world production loads over time.
Securing operational integrity: the journey at Equans Sci-Tech
The validation process begins at the design stage with the development of the project validation plan (PVP)—the overarching document that defines the validation requirements, scope, and responsibilities for the entire project. Close collaboration ensures compliance via the user requirement specification (URS) and requirements traceability matrix (RTM), culminating in a design qualification (DQ) to formally document that the proposed system meets all regulatory standards.
Following design approval, installation qualification (IQ) and operational qualification (OQ) protocols are executed, providing documented evidence that the system has been correctly installed and operates reliably within defined parameters. Finally, the validation team maintains oversight of all commissioning activities to ensure seamless integration with the validation schedule, resulting in a comprehensive validation summary report (VSR) which confirms overall regulatory compliance and fitness for the intended purpose.
Find the answers to your questions
Commissioning is an engineering process to ensure equipment works; Qualification is a formal, documented process required by regulators (like the MHRA) to prove the equipment meets quality standards. We handle both.
Our integrated team identifies the root cause immediately. Because we manage both the construction and the validation, we can implement technical fixes and re-test without the delays of third-party
By having our own specialists, we eliminate the "knowledge gap" that often exists between construction and compliance. Our validation team is involved from the design stage, ensuring that the installation is "born compliant." This integrated approach reduces project timelines, minimizes rework, and provides a single point of accountability for your final Validation Summary Report (VSR).
We treat commissioning and validation as an integrated sequence rather than two separate events. Our in-house team uses a Requirements Traceability Matrix (RTM) to ensure that every technical system is tested for operational performance at the exact moment the build allows. This prevents the common industry pitfall of having to "re-test" systems once the cleanroom is already sealed.
The PVP is established at the very beginning of our engagement. It serves as the master governance document that defines the scope, responsibilities, and acceptance criteria for the entire project. By setting these parameters early, we ensure that every phase of the "Deliver" cycle—from procurement to final testing—is aligned with your regulatory goals and the final Design Qualification (DQ).
Contact Sarah FRANKLAND, our Validation and Regulatory Affairs Manager
Contact Sarah FRANKLAND, our Validation and Regulatory Affairs Manager
Discover more
Our commitment to GMP compliance is just the beginning. To learn more about our end-to-end mission-critical capabilities, including turnkey installations and technical consultancy, explore our related services pages.
Ready to discuss your next project ?
Our specialist team is ready to help you navigate the complexities of pharmaceutical facility design, construction, and validation.Ready to discuss your next project ?
Our specialist team is ready to help you navigate the complexities of pharmaceutical facility design, construction, and validation.