Commissioning, Qualification & Validation (CQV)

Comprehensive CQV Strategy Guarantees Successful Startup

Commissioning, Qualification and Validation (CQV) activities play a crucial role in delivering operationally effective and compliant facilities, utilities, equipment and process. We support our clients throughout the full CQV life cycle, from early stage of user requirements gathering to start-up and operations handover. A comprehensive approach is taken together with the client’s interdisciplinary team during CQV process to facilitate a timely and cost-effective solution. During the course of our engagement, we continually educate your team, to facilitate knowledge transfer and ensure long-term sustainability.

Process Control Systems (PCS)

Process Control Systems (PCS) comprise of the majority of the manufacturing systems used on the pharma shop floor. We apply an effective science-based Quality Risk Management (QRM) approach in PCS qualification based on the product and process understanding to reduce risk to product quality, patient safety, data integrity, while potentially saving time and effort.

At Brevitas, we are always on the lookout for evolving landscape and trends (e.g. Pharma 4.0, Validation 4.0, ATMP, Single Use Technology) in the regulatory environment to streamline our CQV approach to better meet industry compliance and your business requirements.

CQV Services

Experienced in the vertical take-off after construction completion, we deliver value to your projects through the following CQV services:

Apply Quality Risk Management (QRM) approach for integrated commissioning and qualification activities that focus on product quality and patient safety
Attain quality compliance to regulatory requirements and alignment with business goals
Achieve technical assurance for the impacted systems and processes
Utilize paperless validation software, such as Kneat e-validation software, to deliver compelling productivity, cycle-time and compliance improvements across the entire CQV life cycle
Ensure operational readiness for turnover
Deliver project with high-quality on-time & on-budget