CSV & CQV Expertise
Depth & breath of knowledge across design and commercial manufacturing
The core of our compliance services are in the support of vendor FATs/SATs and the preparation, execution, and report generation of IQ/OQ/PQ protocols. We deliver strategic and innovative testing approaches during the planning and execution of capital projects to deliver schedule certainty, reducing cost and minimizing risk.
“We have an eye for detail and technical execution experience.”
We can deliver cost effective documentation generation and test execution services. Our qualification methods meet the latest regulatory requirements and are compliant with site requirements.
Validation & Commissioning Services
Our validation team has extensive GAMP automation, software and data integration experience and can ensure that your systems are 21 CFR Part 11 compliant
Execution Experience
We apply industry best practices to help our clients develop and implement lean efficient, effective, and fully compliant CQV programs
SDLC Documentation
The core of our compliance services is in the support of vendor FATs/SATs and the preparation, execution, and report generation of IQ/OQ/PQ protocols.
Automated Systems
Validation of end to end Design compliance of instrument IO, PLC - OPC Server - DCS Tag - Historian configuration. We test across the Integrated industrial Network
Field Instrument Verification
In-depth verification of measuring instrument data flow with documented proof of compliance to specifications
Technical Expertise
Our team of experts will also install the systems on-site, with an additional check of quality and function prior to the first use.
Quality Management
Our team of experienced quality professionals aim to support quality system audits, policy and procedure development.