Renovo, which develops 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."
GxPi
