CAVE frequently executes validation projects on a fixed price basis or offers our experienced Validation Consultants or Validation Engineers at an hourly rate basis that work out of our office or on your site. After many years of consulting and working in validation our experts have gathered a formidable library of key project documents, ranging from Validation Master Plans, User Requirements Specifications (URS), Functional Specifications (FS) and Detailed Design Specifications, so we can comfortably and efficiently gather and document your key requirements.
Our documents are designed and laid out to promote the efficient generation of qualification protocols such as IQ, OQ and PQ from similar past projects. We do the benchmarking for you. However, its not just the documents but the hands on practical in the trenches experience which is invaluable and access to colleagues with this professional knowledge.
Whether it is an existing facility, or a brand new facility manufacturing pharmaceuticals, medical devices or biologics; our engineers can navigate their way through the regulations and help you set up a compliant and practical validation approach and you can have confidence.
We can develop a robust, cost-effective compliant quality management system (QMS) focused on risk to patients and product quality. We supply expert professionals focused on providing solutions that ensure clients remain compliant with regulations and industry standards.
We review the business case for unassessed risk and customize comprehensive solutions that are compliant. We assess the life-cycle model to focus on a risk-based approach that will harmonize requirements across engineering, maintenance, IT, metrology, validation, analytical, and quality reducing your overall financial investment to maintain the performance of a facility and its products.
CAGE CODE: 8VTL8
DUNS: 128654228
Email:
info@cave-solutions.com
Phone:
984 268-7220
Address:
4804 Page Creek Lane, Suite 232,
Research Triangle Park, NC 27793
MBE
National Minority Supplier Development Council (NMSDC)
NCSBEm
HUB (pending)
SBA (pending)
WOSB (pending)
Kneat Partnership