Regulatory compliance service and product provider GxPi announced today that its x-docs™ CAPA Module has been selected by Renovo as a hosted system to manage vital documents for the company’s drug development process. Renovo uses the GxPi Corrective Action and Preventive Action (CAPA) Module, which is part of the x-docs™ portfolio, to electronically track and manage its Corrective and Preventative management programme. Used in a hosted system environment, the CAPA Module minimises installation costs thereby reducing the overall implementation and licensing costs of the product for the customer. For more information on GxPi’s work with Renovo and to download the case study please visit gxpi.com.
Renovo, a leader in the discovery and development of drugs to reduce scarring, improve wound healing and enhance tissue regeneration, uses a predominantly paper-based documentation system where documents are circulated for approval and stored in a central repository. Current regulations require that a robust CAPA process is in place and that pharmaceutical organisations can demonstrate that a thorough assessment of corrective and preventative actions has been made within a given timeframe. To achieve regulatory compliance, Renovo decided to integrate an electronic system with its existing processes, selecting the GxPi CAPA Module for use as a hosted system from the GxPi data centre, due to its flexibility and ease of configuration.
Using the CAPA Module as a hosted system has removed the need for Renovo to carry out extensive installation qualification, leaving more time to focus on performance qualification testing of the system against pre-defined user requirements, as well as significantly reducing implementation and maintenance costs. The system also enables greater visibility of CAPAs across all departments without comprising the safety of data, as it is accessed remotely by authorised users via a secure internet connection to GxPi’s validated servers.
x-docs is a modular platform built on Microsoft SharePoint and facilitates simple compliance with industry regulations. The CAPA Module is based on the principle of ‘continuous improvement’, minimising delays to product and document release and sign off by enabling the efficient handling of workflow issues. As all information on any given CAPA is contained within one document, information can be handled efficiently with minimal risk of error. Being a validated electronic system, the CAPA Module also provides the assurance that approved CAPAs cannot be altered once data are submitted.
Keith Williams, CEO, GxPi, comments: “We are extremely proud to have been selected by such a prestigious organisation, leading the way in biopharmaceutical innovations. The whole integration process has been smooth and the fact that Renovo is using the module as a hosted system has reduced their overall implementation costs.”
Steve Lomax, VP Quality Assurance, Renovo commented: “We have been really impressed with the way the CAPA Module has integrated with our existing processes. Within the system, we can manage, track and resolve quality issues effectively. This helps us to maintain regulatory compliance and also raises awareness across departments of their requirements to comply with regulatory standards of GMP and GCP activities in the clinical development of pharmaceutical products.”
For more information on GxPi, please call +44 (0) 115 924 8477 or email info[.]gxpi.com. Alternatively please visit the website for further information.
GxPi (gxpi.com) provides consultancy services and compliance-based products to the biotechnology, pharmaceutical, consumer healthcare, medical devices and veterinary industries, enabling the development and management of compliant content. The company’s consultancy arm includes high quality, results-focused regulatory compliance (GMP, GAMP, GLP, GEP, GCP, GxP), qualified person (QP), quality assurance (QA), project management, validation, process engineering, computer systems, laboratory equipment, project management, design studies, training and clinical technology consulting services. GxPi also offers Enterprise Content Management (ECM) solutions to the life sciences sector. This provides a new class of document management software which is powerful and practical in enabling sponsors and Contract Research Organisations to comply with increasing regulatory requirements. The solutions are easy to configure, require little IT support, are cost-effective for organisations of all sizes and are entirely intuitive to use with minimal training.