GxP (GMP, GLP, GCP) Regulated Industries are required to provide evidence and associated validation documentation to ensure that their business critical computerized systems, applications, and equipment have been developed according to quality software engineering principles, and that each system provides the functionalities required by its users and adhere to regulatory requirements including 21 CFR Part 11. CXV Global’s professionals have been trained to make validation an integral part of their technical development process, which ensures that the computer- based systems we develop will meet the necessary qualifications in an efficient and timely manner.
CXV Global has developed qualification, validation and system life-cycle documentation for a variety of GxP critical computer-based systems. Some of these systems include Laboratory Information Management Systems, Electronic Lab Notebooks, Manufacturing Executions Systems, Serialization, Data Integrity Systems, SCADA systems, Machine Vision systems, and a whole host of lab/manufacturing equipment and instruments. These systems are used in controlling the research and production processes and operations used to manufacture and release regulated products, and to collect, analyze, manage and archive data.
CXV Global follows an in-depth methodology that requires specific activities and deliverables that ensure operational and regulatory compliance of computer- controlled systems. Our professionals will carry out the process of validating your company’s computerized systems by first reviewing and understanding your company’s existing procedures and guidelines, and using our expertise to develop all necessary documentation to ensure proper validation of your systems. Our experience stems from years of developing and implementing automation solutions in regulated environments, utilizing our strict Software Development Life Cycle. Our experience reaches from the laboratories, to clinical packaging areas, to the real- time process areas, including the packaging lines, and the supply chain systems.
CXV Global’s established track record of designing and implementing turn-key automation solutions that comply with the full spectrum of GMP/GLP/GCP regulations is the basis for the system solutions we offer our clients. Our professionals have been trained to under-stand at a detailed level the Computer System Validation Process, including 21 CFR Part 11, and are ready to assess and develop computer system validation compliance strategies for old and new systems in the Pharmaceutical, Biotechnology, and Medical Device industries.
With a focus on Digital Transformation, CXV Global also offers validation and compliance solutions and services utilizing digital validation platforms that reduce costs and drive efficiencies in the validation process and overall system life-cycle maintenance. Whether providing full CSV services for a new system, or providing risk assessment & remediation services for legacy systems, CXV Global is the ideal resource for your company’s validation and compliance needs. Our Validation and Compliance expertise includes the following areas:
Your source for GxP-compliant Computer System Validation (CSV) protocols and the application of strict system development life-
cycle documentation and procedures