Commissioning, Qualification, and Validation
Whether you're building a new facility, installing a new state-of-the-art automated packaging line, or calibrating a balance, you must have complete control – and be able to prove it.
Our clients' success and credibility depend on their manufacturing facilities operating consistently and reliably year after year. Commissioning, qualification, and validation are core capabilities for Raland and represent a significant portion of our business.
For years, we have helped our clients achieve the highest levels of efficient product throughput possible, for the highest level of profitability, while meeting industry regulations.
Commissioning and Qualification
New facilities or expansion is critical for growth, and the truth of the matter is that building contractors don’t always focus on the most efficient method for qualification and validation of your utilities and equipment. In our experience, including a C&Q Manager on the initial facility design can help to ensure that the finished facility comes in on time, on budget, and all utilities and equipment perform as expected and designed.
Raland C&Q Managers are adept at leveraging commissioning activities such as FAT, SAT, systems start-up, integration, and functional performance testing to minimize qualification and validation activities saving time and money. Commissioning should never be an afterthought.
Validation
Our approach to Validation is holistic, in that no piece of equipment or utility operates in a vacuum and once installed or modified must be validated in the context of the related process or activity. We utilize a combination of design capabilities, user requirements, regulatory requirements and industry best practices to deliver a right-sized solution that also meets the customer needs and expectations.
Our typical validation projects include the following activities:
- Validation Project Planning
- Development of Requirement Specifications
- IQ/OQ/PQ Protocol Development
- Validation Execution
- Final Reports and Turnover
Our Validation team has years of experience and deep expertise with the following types of validation projects:
- Equipment Validation
- Facilities & Environmental Validation
- HVAC System Validation
- Cleaning Validation
- Process Validation
- Laboratory Equipment and Instrumentation Validation
- Analytical Method Validation
- Computer System Validation (Click here to see our CSV services)