Definitely, We can serve you better!
- Development of Validation strategy documents based on the client requirement.
- Develop C&Q scheduling & resource planning.
- Integrated CSV.
- Development of System Impact Assessments, Risk Assessment, URS.
- Development of project SOPs ,CQV templates.
- Development of Requirement traceability matrix.
- Development of C&Q plans for individual disciplines like process, clean utility, black utility, HVAC, QC instruments, GAS systems, BMS and EMS systems.
- Review of Vendor DQ documents, FAT and SAT protocols.
- Development of GXP assessment document for the project.
- Development IQ and OQ protocols considering integrated approach with CSV requirements.
CQV Support
CQV (Commissioning, Qualification, and Validation) is a very detail-oriented process that requires the right mix of knowledge, experience, and diligence to correctly place equipment/systems into use.
Additionally, with FDA regulations and requirements continually changing, it is crucial to understand the CQV process to remain compliant. Before starting a CQV project on any facility, utility or process system, consider the initial steps required.
Definitely, We can serve you better!
- Support client for FAT execution.
- Participate in the Mechanical walkdowns for all the systems.
- Support client for SAT execution.
- Develop IQ/OQ protocols and witnessing of executions.
- Project tracking and coordinating with vendors, clients.
CQV Support
CQV (Commissioning, Qualification, and Validation) is a very detail-oriented process that requires the right mix of knowledge, experience, and diligence to correctly place equipment/systems into use.
Additionally, with FDA regulations and requirements continually changing, it is crucial to understand the CQV process to remain compliant. Before starting a CQV project on any facility, utility or process system, consider the initial steps required.