Commissioning Agents specializes in the commissioning and start-up of production facilities, including utilities, process equipment and control systems. Our commissioning projects have ranged from single systems to the largest biotech facilities. We assemble a team of the right size and experience to match your project needs.
Our teams can:
- Develop and implement commissioning plans.
- Effectively plan and coordinate the quality assurance activities of vendors, construction contractors, owners, and contract resources.
- Develop commissioning inspection and test procedures, forms, and protocols tailored to project specifications to guide and document these activities.
- Integrate our work within the overall project schedule, establishing an optimal system commissioning sequence to minimize project delivery timelines.
- document the inspections, start-up, and initial testing of equipment to streamline later validation activities.
When problems arise, we take charge, we take responsibility and we ensure re-testing is thorough, documented and completed quickly to stay on schedule. Our teams have the engineering, operational and regulatory experience to identify and implement the best solutions.
Commissioning Agents is the leader in our industry for effectively integrating commissioning and qualification to achieve regulatory compliance and project business objectives.
The result: Facilities and equipment are commissioned more quickly and with fewer problems.
Validation
From the start of validation planning through the final report and FDA approval, you need a team you can count on for expertise and performance. Your validation contractor must be able to combine proper documentation, objective quality assurance, initiative, dedication, and good project management to achieve both regulatory compliance and business success.
We develop validation master plans, protocols (IQ/OQ/PQ), perform field inspections, conduct testing, and generate final reports. We have a strong reputation for determining the appropriate level of inspection or test needed to achieve the high degree of assurance required by the FDA and other regulatory agencies.
We have performed hundreds of validation projects for dozens of clients. We have experience with equipment qualification, computer validation, cleaning validation, sterilization validation, laboratory instruments and methods validation, and process validation.
We understand how to leverage the quality assurance activities of vendors, factory acceptance tests, construction quality assurance, and commissioning activities to avoid duplication and streamline the final validation inspections and tests. This shortens the final stages of project delivery, when just about everything is on the critical path.
The result: Faster time to market for your product!
Major Services
Facility Commissioning and Validation
- Commissioning and validation planning
- Commissioning project management
- Factory acceptance testing
- Commissioning procedures, inspection and test forms
- Equipment and system installation inspections
- Start-up and troubleshooting
- Commissioning testing
- Validation protocol writing
- Protocol field execution and reports
- Computer validation, cleaning validation, sterilization validation, product validation
